MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-18 for BARDIA? FOLEY CATHETER SILICONE COATED 123616A manufactured by C.r. Bard, Inc. (covington) -1018233.
[188334490]
The reported event was inconclusive, as the device was not returned for evaluation. However, the potential root cause for this failure mode could be user related (example: over aspirated, incorrect syringe)/ collapse lumen/ sac close eye/ valve damage. 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: "caution: this product contains natural rubber latex which may cause allergic reactions. Sterile unless package is opened or damaged warning: do not use ointments or lubricants having a petrolatum base. They will damage latex and may burst balloon. Do not aspirate urine through drainage funnel wall. Single use only. Do not resterilize. For urological use only. Valve type: use luer syringe. Do not use needle. 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. Use only gentle aspiration to encourage deflation if needed. Vigorous aspiration may collapse the inflation lumen. If permitted by hospital protocol, the may be cut off. If this fails, contact an 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
[188334491]
It was reported that the catheter was difficult to deflate on the 6th day after placement. The doctor was able to remove the catheter by inserting a guidewire into the urethra to pierce the catheter balloon, but this action caused an injury to the wall of the urethra. Then the guidewire was used through the inflation lumen to clear the occlusion, and remove the catheter. The removed catheter balloon was intact, but the patient experience increased pain through the process. Per additional information from the ibc via email 09mar2020, the events reported above were confirmed as correct from the complainant. No additional medical intervention was done for the injured urethral wall or for the increased pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01884 |
| MDR Report Key | 9848491 |
| Report Source | OTHER |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2018-02-21 |
| 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 |
| 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 | BARDIA? FOLEY CATHETER SILICONE COATED |
| Generic Name | BARDIA 2 WAY CATHETER |
| Product Code | KOD |
| Date Received | 2020-03-18 |
| Catalog Number | 123616A |
| Lot Number | MYCPRC34 |
| 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 | 1. Required No Informationntervention | 2020-03-18 |