MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-05 for BARD DISPOZ-A-BAG LEG BAG UNKNOWN manufactured by Productos Para El Cuidado De La Salud -9611590.
[61710797]
The device was not returned for evaluation. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use states the following: "visually inspect the product for any imperfections or surface deterioration prior to use. If package is opened or if any imperfection or surface deterioration is observed, do not use. The urine meter may be emptied in two ways: a. To empty into the bag, grasp the bottom of the meter and lift up. To provide better meter drainage, lifting again is recommended. B. To empty urine meter into receptacle, twist green portion of drain valve to the left; to close, twist green portion of the drain valve to the right. To empty bag: a. Remove outlet tube from housing; gently squeeze connector arms and pull tube from housing. B. Release clamp and empty bag. C. After emptying, reclamp outlet tube and slide connector into housing until connector arms engage. Empty the collection bag regularly (e. G. , prior to transport) using a separate, clean collection container for each patient. Periodic observations of this system should be made to ensure that urine is flowing freely. If a standing column of urine is observed, check for correct positioning of bag and then for a physical obstruction. If correct positioning or removal of physical obstruction does not allow free flow, the bag may have to be changed. " (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
[61710798]
It was reported that there was a kink in the tubing and as a result, no urine would flow. The complainant stated that the leg bag was replaced with a new one. No patient injury was reported and no medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2016-01745 |
| MDR Report Key | 6144255 |
| Date Received | 2016-12-05 |
| Date of Report | 2016-11-18 |
| Date Mfgr Received | 2016-11-18 |
| Date Added to Maude | 2016-12-05 |
| 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 | 0 |
| Brand Name | BARD DISPOZ-A-BAG LEG BAG |
| Generic Name | LEG BAG |
| Product Code | FAQ |
| Date Received | 2016-12-05 |
| Catalog Number | UNKNOWN |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-12-05 |