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 2020-03-11 for BARDEX? ALL-SILICONE FOLEY CATHETER 165816 manufactured by C.r. Bard, Inc. (covington) -1018233.
[186697352]
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
[186697353]
It was reported that there was an issue with the foley catheter upon removal. The complainant reported that it took 9 attempts to remove the catheter and when they finally removed it, there was bleeding noted. The catheter was reportedly observed to have 'rolled' on itself in the balloon area upon removal. The complainant noted that the associates cut the tip off the catheter to be able to share what was experienced. No medical intervention was reported. The associates reportedly used another catheter to help troubleshoot, and experienced the same issue with the rolling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01751 |
| MDR Report Key | 9820140 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-11 |
| 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 | BARDEX? ALL-SILICONE FOLEY CATHETER |
| Generic Name | FOLEY CATHETER |
| Product Code | EZL |
| Date Received | 2020-03-11 |
| Returned To Mfg | 2020-03-11 |
| Model Number | 165816 |
| Catalog Number | 165816 |
| Lot Number | NGDX1806 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-11 |