MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-01-03 for BARD? URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER 154002 manufactured by C.r. Bard, Inc. (covington) -1018233.
[178331376]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[178331377]
It has been reported that there were many instances where the urinary drainage bag allegedly "air locked", which prevented the urine to drain from the bladder into the bag. It lead to discomfort for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-00104 |
| MDR Report Key | 9548868 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-01-03 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-12-08 |
| Date Mfgr Received | 2020-01-05 |
| Device Manufacturer Date | 2019-07-05 |
| Date Added to Maude | 2020-01-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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? URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER |
| Generic Name | DRAIN BAG |
| Product Code | KNX |
| Date Received | 2020-01-03 |
| Catalog Number | 154002 |
| Lot Number | NGDS3524 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-03 |