MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-03-19 for BARDEX? LUBRI-SIL? ALL-SILICONE TEMP SENSING FOLEY CATHETER 119208M manufactured by C.r. Bard, Inc. (covington) -1018233.
[186334634]
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
[186334635]
It was reported that the 8 fr temp-sensing foley was found to be not patent after attempted insertion in a patient. Per additional information received, the foley did not drain. When the urologist came to assist, he examined the foley after the removal and there was no hole in the end of the foley for the urine to drain out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01959 |
| MDR Report Key | 9856402 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-19 |
| 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 TEMP SENSING FOLEY CATHETER |
| Generic Name | TEMP SENSING FOLEY |
| Product Code | EZL |
| Date Received | 2020-03-19 |
| Model Number | 119208M |
| Catalog Number | 119208M |
| Lot Number | NGDU1415 |
| Device Availability | Y |
| 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 | 2020-03-19 |