MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-24 for BARD DISPOZ-A-BAG LEG BAG WITH RUBBER CAP VALVE (ONE PAIR OF LATEX STRAPS) 150103 manufactured by Productos Para El Cuidado De La Salud -9611590.
[68597397]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[68597398]
It was reported that the drain bag was leaking from the bottom of the bag. It was later reported that the bag leaked urine onto the patient's (b)(6) on a saturday evening, after he had the bag on for approximately two weeks. The patient reported that he was removing the rubber cap approximately 6x per day to drain fluid from those two weeks of use. The patient attempted to seal the leak with packaging and duct tape; however, was unsuccessful. Subsequently, the patient placed the bag into a bucket in a "(b)(6)" freezer bag, and taped it to his leg. The patient stated that he slept sitting in a chair all night, to keep his bag vertical. The following day (sunday), the patient went to (b)(6) hospital emergency room to have the catheter removed. The catheter and bag were previously scheduled to be removed on monday; therefore, the catheter and bag were not replaced, as the patient no longer needed the device.
Patient Sequence No: 1, Text Type: D, B5
[70208836]
No physical sample was returned for evaluation. However, a photo sample was received. During the visual evaluation of the photo received, there was a gray tape on the bottom of the leg bag. Due to the gray tape it was not possible to confirm the defect reported by the customer. Therefore, the reported event was inconclusive due to the poor sample condition. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use state the following: "this is a single use device. Do not resterilize any portion of this device. Reuse and /or repackaging may create a risk of patient or user infection. Compromise the structural integrity and /or essential material and design characteristic of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient. " (b)(4). Correction = device available for evaluation? And device evaluated by mfr? The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Received a photo sample only.
Patient Sequence No: 1, Text Type: N, H10
[70208837]
It was reported that the drain bag was leaking from the bottom of the bag. It was later reported that the bag had leaked urine onto the patient's lzboy on a saturday evening, after he had the bag on for approximately two weeks. The patient reported that he was removing the rubber cap approximately 6x per day to drain fluid from those two weeks of use. The patient attempted to seal the leak with packaging and duct tape; however, was unsuccessful. Subsequently, the patient placed the bag into a bucket in a (b)(6) freezer bag, and taped it to his leg. The patient stated that he slept sitting in a chair all night, to keep his bag vertical. The following day (sunday), the patient went to harris methodist hospital emergency room to have the catheter removed. The catheter and bag were previously scheduled to be removed on monday; therefore, the catheter and bag were not replaced, as the patient no longer needed the device.
Patient Sequence No: 1, Text Type: D, B5
[87056265]
No physical sample was returned for evaluation; however, a photo sample was received. During visual evaluation a cut was observed between circular and flat seal at the right side of the outlet tube in the bottom of the leg bag. The cut measured 0. 290? , the cut pass through the flat seal. Further, the peripheral seal of the bag was inspected, and no discrepancies were found. Also inspected the front and back of the clear vinyl and no discrepancies were noticed. The rest of the components of the leg bag, looking for sharp edges and/or irregular areas and no problem observed. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use state the following: "this is a single use device. Do not resterilize any portion of this device. Reuse and /or repackaging may create a risk of patient or user infection. Compromise the structural integrity and /or essential material and design characteristic of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient. " (b)(4). The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[87056266]
It was reported that the drain bag leaked from the bottom of the bag. It was later reported that the bag leaked urine onto the patient's lzboy on a saturday evening, after he had the bag on for approximately two weeks. The patient reported that he was removing the rubber cap approximately 6x per day to drain fluid from those two weeks of use. The patient attempted to seal the leak with packaging and duct tape; however, was unsuccessful. Subsequently, the patient placed the bag into a bucket in a "ziploc" freezer bag, and taped it to his leg. The patient stated that he slept sitting in a chair all night, to keep his bag vertical. The following day (sunday), the patient went to (b)(6)hospital emergency room to have the catheter removed. The catheter and bag were previously scheduled to be removed on monday; therefore, the catheter and bag were not replaced, as the patient no longer needed the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-00677 |
| MDR Report Key | 6358770 |
| Date Received | 2017-02-24 |
| Date of Report | 2017-06-13 |
| Date Mfgr Received | 2017-05-26 |
| Device Manufacturer Date | 2016-05-10 |
| Date Added to Maude | 2017-02-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY GRAVLEY |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 |
| Manufacturer Street | KM. 7 CARRETERA INTERNACIONAL |
| Manufacturer City | NOGALES, SONORA 85621 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 85621 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD DISPOZ-A-BAG LEG BAG WITH RUBBER CAP VALVE (ONE PAIR OF LATEX STRAPS) |
| Generic Name | DRAIN BAG |
| Product Code | FAQ |
| Date Received | 2017-02-24 |
| Returned To Mfg | 2017-04-24 |
| Catalog Number | 150103 |
| Lot Number | NGAX3095 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 |
| Manufacturer Address | KM. 7 CARRETERA INTERNACIONAL NOGALES, SONORA 85621 MX 85621 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-24 |