MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-27 for BARDIA? FOLEY CATHETER SILICONE COATED 123616A manufactured by C.r. Bard, Inc. (covington) -1018233.
[185255936]
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: contact with sharp object)/ mechanical failure/ operator error/ thin rubberize layer. 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. "
Patient Sequence No: 1, Text Type: N, H10
[185255937]
It was reported that on (b)(6) 2019, the patient underwent the ureteroscope lithotripsy on the right side under general anesthesia. Intraoperatively, a urethral catheter was indwelled, which went smoothly. On the same day of the surgery, a nurse found that the urethral catheter had fallen out spontaneously. The patient was re-indwelled and experienced increasing pain. The removed urethral catheter and balloon were complete.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-02173 |
| MDR Report Key | 9889307 |
| Report Source | OTHER |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2019-12-25 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-02-20 |
| Date Added to Maude | 2020-03-27 |
| 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 FOLEY CATHETER |
| Product Code | KOD |
| Date Received | 2020-03-27 |
| Catalog Number | 123616A |
| Lot Number | MYCZ5289 |
| 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 | 2020-03-27 |