MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-02-13 for BARD? CLOSED SYSTEM URINARY DRAINAGE BAG N153504 manufactured by C.r. Bard, Inc. (covington) -1018233.
[183257299]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[183257300]
It was reported that the anti-reflux valve was allegedly obstructed and there was no urine in the bag. The caregiver tried unclipping at the bottom to open the flow, but that did not work. Next they separated the bag from the foley then lifted the tubing to see if it would drain and jiggled the bulb to no avail. The bag remained dry.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01031 |
| MDR Report Key | 9708016 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-02-13 |
| Date of Report | 2020-03-23 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2019-10-23 |
| Date Added to Maude | 2020-02-13 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD? CLOSED SYSTEM URINARY DRAINAGE BAG |
| Generic Name | CANADA URINE BAG |
| Product Code | KNX |
| Date Received | 2020-02-13 |
| Returned To Mfg | 2020-01-28 |
| Catalog Number | N153504 |
| Lot Number | NGDW0574 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-13 |