MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-12 for BARDIA 2000ML CLOSED SYSTEM URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER 802001 manufactured by Productos Para El Cuidado De La Salud -9611590.
[72800828]
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.
Patient Sequence No: 1, Text Type: N, H10
[72800829]
It was reported that the drainage bag was missing the drainage inlet tubing.
Patient Sequence No: 1, Text Type: D, B5
[75856057]
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.
Patient Sequence No: 1, Text Type: N, H10
[75856058]
It was reported that the drainage bag was missing the drainage inlet tubing.
Patient Sequence No: 1, Text Type: D, B5
[87005205]
Received one unopened drainage bag product, one opened extension tubing product (does not belong to the structure of the product) , and one cut piece of extension tubing (does not belong to the structure of the product). The reported event was unable to be confirmed as the problem could not be reproduced. Per the visual inspection, the package was opened and all components were present and of according to the structure of the product. No obvious defects were noted with the components of the drainage bag. The bag and all components were according to the structure of the product. 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: "-remove protective cap from drainage tube and connect drainage tube adapter to catheter. -fasten drainage bag to bedframe near the foot of the bed. Do not allow bag to touch floor. Important: hang drainage tube in a straight fashion from bedside to drainage bag. If drainage bag is placed even with patient? S hip, coil tubing alongside patient. Tubing should be draped over patient? S leg. -check that urine is draining into bag. " (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
[87005206]
It was reported that the drainage bag was missing the drainage inlet tubing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-01742 |
| MDR Report Key | 6487394 |
| Date Received | 2017-04-12 |
| Date of Report | 2017-06-13 |
| Date Mfgr Received | 2017-05-27 |
| Device Manufacturer Date | 2017-02-08 |
| Date Added to Maude | 2017-04-12 |
| 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 |
| 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 | BARDIA 2000ML CLOSED SYSTEM URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER |
| Generic Name | DRAIN BAG |
| Product Code | FAQ |
| Date Received | 2017-04-12 |
| Returned To Mfg | 2017-04-04 |
| Catalog Number | 802001 |
| Lot Number | NGBN1511 |
| Operator | LAY USER/PATIENT |
| 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 | 2017-04-12 |