MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-18 for LATEX FOLEY CATHETER UNK manufactured by C.r. Bard, Inc. (covington) -1018233.
[183912802]
The reported event was inconclusive, as the device was not returned for evaluation. However, a potential root cause for this failure mode could be a result of over inflation and/or extended indwelling periods. The lot number is unknown; therefore, the device history record could not be reviewed. Although the product family is unknown, the foley catheters ifus are found to be adequate based on past reviews.
Patient Sequence No: 1, Text Type: N, H10
[183912803]
It was reported when a foley catheter was removed it was found that the balloon had collapsed on itself. It was also noted that a ring had developed around the end of the foley by the balloon, which made it difficult to remove. The rapid response nurse mentioned that she had seen it happen before, but never reported it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01875 |
| MDR Report Key | 9848170 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-18 |
| 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 | RISK MANAGER |
| 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 | LATEX FOLEY CATHETER |
| Generic Name | FOLEY CATHETER |
| Product Code | EZC |
| Date Received | 2020-03-18 |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 | 2020-03-18 |