MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other,user facili report with the FDA on 2020-01-06 for BARD? URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER 154002 manufactured by C.r. Bard, Inc. (covington) -1018233.
[173969037]
The reported event was inconclusive, as the device was not returned for evaluation. A potential failure mode could be? Urine will not flow through tubing? With a potential root cause of "kinked tubing". The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use were found adequate and state 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 device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[173969038]
It was reported that the tubing kinked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-00133 |
| MDR Report Key | 9554899 |
| Report Source | DISTRIBUTOR,OTHER,USER FACILI |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-06 |
| Date Mfgr Received | 2019-12-16 |
| Date Added to Maude | 2020-01-06 |
| 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? URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER |
| Generic Name | DRAIN BAG |
| Product Code | KNX |
| Date Received | 2020-01-06 |
| Model Number | 154002 |
| Catalog Number | 154002 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-01-06 |