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 2020-03-17 for BARDEX? FOLEY CATHETER SILICONE COATED 0167V20S manufactured by C.r. Bard, Inc. (covington) -1018233.
[183936587]
The reported event was inconclusive, as the device was not returned for evaluation. However, a potential root cause for this failure mode could be bad fit with shaft/no drainage eye/ poorly seated balloon /bladder neck interface. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use were found adequate and state the following: "see labeling attached to section root cause summary. Caution state "single patient use only. Do not reuse. Do not resterilize. For urological use only. Visually inspect the product for any imperfections or surface deterioration prior to use. "
Patient Sequence No: 1, Text Type: N, H10
[183936588]
It was reported that the catheter leaked. Per additional information received via email on 9 march 2020 from ibc representative, water leaked from the catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01871 |
| MDR Report Key | 9844696 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-05-25 |
| Date Added to Maude | 2020-03-17 |
| 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? FOLEY CATHETER SILICONE COATED |
| Generic Name | BARDIA FOLEY CATHETER |
| Product Code | KOD |
| Date Received | 2020-03-17 |
| Catalog Number | 0167V20S |
| Lot Number | MYDT3010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-17 |