MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-08-21 for BARD URINE DRAINAGE COLLECTION BAG NI manufactured by C.r. Bard, Inc..
[111400]
Rptr writes, "since our discussion of april 21st we have continued to have problems with the bard urine drainage collection bags. As you know, these bags will self adhere and prevent urine drainage if the vent located on the front of the bag gets wet. Per your suggestion, we did education with staff about the need to keep the vent dry. We have found that in spite of all our efforts, in routine care of patients in clinical settings (repositioning, moving from stretcher to bed etc) the collected urine does saturate the vent. Each time the vent becomes saturated, the urine collection bag must be replaced or there is the risk of the sides of the bag sticking together and preventing urine drainage. We believe the design of the bag is flawed; the vent placement allows for easy saturation and malfunction. Have you considered a change in the design of the product? I am interested in hearing from you with additional suggestions to prevent future problems with the bard bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1014460 |
| MDR Report Key | 183966 |
| Date Received | 1998-08-21 |
| Date of Report | 1998-08-21 |
| Date Added to Maude | 1998-08-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD URINE DRAINAGE COLLECTION BAG |
| Generic Name | URINE DRAINAGE COLLECTION BAG |
| Product Code | EYZ |
| Date Received | 1998-08-21 |
| Model Number | NI |
| Catalog Number | NA |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 178853 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 5425 W. AMELIA EARHART DR SALT LAKE CITY UT 84116 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-08-21 |