MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-03-12 for BARDEX? LUBRICATH? FOLEY CATHETER 0165L18 manufactured by C.r. Bard, Inc. (covington) -1018233.
[183264498]
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
[183264499]
It was reported that the catheter balloon was difficult to deflate on the 5th day after placement. The urologist cut the catheter lumen and the water still did not come out, so a guidewire was used to remove the water. Per additional information from the (b)(4) via email 27feb2020, it was just reported that the guidewire was used in order to remove the water, and the catheter balloon did not appear to be burst or puncture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01778 |
| MDR Report Key | 9824444 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-19 |
| 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 |
| 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? LUBRICATH? FOLEY CATHETER |
| Generic Name | FOLEY CATHETER (LATEX) |
| Product Code | EZC |
| Date Received | 2020-03-12 |
| Returned To Mfg | 2020-03-02 |
| Catalog Number | 0165L18 |
| Lot Number | 9HM058 |
| 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 | 1. Required No Informationntervention | 2020-03-12 |