MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-06 for BARDEX? LUBRI-SIL? ALL-SILICONE FOLEY CATHETER 175816 manufactured by C.r. Bard, Inc. (covington) -1018233.
[187855205]
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
[187855206]
It was reported that a new foley was reinserted on (b)(6) 2020 resulted in a cauti. In addition, a drain bag leaked. The product catalog number for the bag was unknown. Per additional information received from the investigators on 13feb2020, one tray with the catheter was received. The bag was leaking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01627 |
| MDR Report Key | 9800860 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-30 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2018-08-31 |
| Date Added to Maude | 2020-03-06 |
| 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 | BARDEX? LUBRI-SIL? ALL-SILICONE FOLEY CATHETER |
| Generic Name | FOLEY CATHETER |
| Product Code | EZL |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2020-02-07 |
| Model Number | 175816 |
| Catalog Number | 175816 |
| Lot Number | NGCV0825 |
| 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 | 1. Other | 2020-03-06 |