MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,other report with the FDA on 2020-01-06 for BARDEX? ALL-SILICONE FOLEY CATHETER 165814 manufactured by C.r. Bard, Inc. (covington) -1018233.
[179797162]
The reported event was inconclusive, as the device was not returned for evaluation. A potential failure mode could be? Balloon collapses? With a potential root cause of "inflation / drainage lumen wall perforated. " the lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use were found adequate and state the following: "to deflate catheter balloon: gently insert a syringe in the catheter valve. Never use more force than is required to make the syringe? Stick? In the valve. If you notice slow or no deflation, re-seat the syringe gently. Allow the balloon to deflate slowly on its own. Do not aspirate or manually accelerate the deflation of the balloon. If permitted by hospital protocol, the valve arm may be severed. If this fails, contact adequately trained professional for assistance, as directed by hospital protocol. Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient. "
Patient Sequence No: 1, Text Type: N, H10
[179797163]
It was reported that the balloon would not hold the saline.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-00119 |
| MDR Report Key | 9553661 |
| Report Source | CONSUMER,DISTRIBUTOR,OTHER |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-06 |
| Date Mfgr Received | 2019-12-16 |
| Date Added to Maude | 2020-01-06 |
| 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? ALL-SILICONE FOLEY CATHETER |
| Generic Name | SILICONE FOLEY CATHETER |
| Product Code | GBM |
| Date Received | 2020-01-06 |
| Model Number | 165814 |
| Catalog Number | 165814 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| 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 | 2020-01-06 |