MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-25 for INFECTION CONTROL URINE DRAINAGE BAG WITH ANTI-REFLUX CHAMBE 154005A manufactured by C.r. Bard, Inc..
[5102185]
The nurse noticed during morning report that the drain tube on the patient's urinary drainage bag was discolored a purplish red. Concerned that the patient had blood in his urine, the nurse opened the drain bag and took a sample for a urinalysis. The urine in the drain bag was golden and the urinalysis came back with no blood found in the urine. At that point it was determined that the drain tube was stained from an unknown source. The urinary drainage bag was changed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4172938 |
| MDR Report Key | 4172938 |
| Date Received | 2014-09-25 |
| Date of Report | 2014-09-25 |
| Date of Event | 2014-09-22 |
| Report Date | 2014-09-25 |
| Date Reported to FDA | 2014-09-25 |
| Date Reported to Mfgr | 2014-10-15 |
| Date Added to Maude | 2014-10-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFECTION CONTROL URINE DRAINAGE BAG WITH ANTI-REFLUX CHAMBE |
| Generic Name | URINARY DRAINAGE BAG |
| Product Code | FCN |
| Date Received | 2014-09-25 |
| Model Number | 154005A |
| Catalog Number | 154005A |
| Lot Number | NGYE0339 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 730 CENTRAL AVE. MURRAY HILL NJ 07974 US 07974 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-25 |