MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-03-12 for BARDEX? ALL-SILICONE FOLEY CATHETER 165814 manufactured by C.r. Bard, Inc. (covington) -1018233.
[186337069]
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
[186337070]
It was reported that the catheter balloon inflated asymmetrically (95% to 5%) ratio. The user tried to troubleshoot by inflating and deflating, but the results were the same. Upon arrival of the sample on (b)(6) 2020, there were two catheters packaged together, and a second complaint was opened for the additional catheter mentioned in an email on 20feb2020. It was reported as an asymmetrical balloon as well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01786 |
| MDR Report Key | 9825326 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-12 |
| 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 | BARDEX? ALL-SILICONE FOLEY CATHETER |
| Generic Name | SILICONE FOLEY CATHETER |
| Product Code | GBM |
| Date Received | 2020-03-12 |
| Returned To Mfg | 2020-02-24 |
| Catalog Number | 165814 |
| Lot Number | NGCX0488 |
| 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 | 2020-03-12 |