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.
[185248468]
The reported event was inconclusive, as the device was not returned for evaluation. However, a potential root cause for this failure mode could be user related (example: contact with sharp object)/ / exposure to petroleum based products mechanical failure/operator error. 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: "applicable scope: foley catheters are intended for use in the drainage of urine from the bladder of children and adults. Caution: this product contains natural rubber latex which may cause allergic reaction. Sterile unless package has been 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 the drainage funnel wall. Single use only. Do not re-sterilize. For urological use only. Before using, please inspect visually whether products are all complete or surface wear. Valve type: use luer slip 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 valve 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. Storage: catheters need to be stored at room temperature and away from direct light, preferably stored in the original packing box. Caution: federal (usa) law restricts this device to sale by or on the order of a physician. "
Patient Sequence No: 1, Text Type: N, H10
[185248469]
It was reported that on (b)(6) 2020, at 11:30 am a urethral catheter was indwelled in the patient. The next morning on (b)(6) 2020, the balloon of the urethral catheter was found to have fallen out with a ruptured balloon. The patient was re-indwelled with a new urethral catheter and experienced increasing pain. There was no missing pieces of the balloon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-02172 |
| MDR Report Key | 9889290 |
| Report Source | OTHER |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-15 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2017-09-29 |
| 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 | FOLEY CATHETER |
| Product Code | KOD |
| Date Received | 2020-03-27 |
| Catalog Number | 123616A |
| Lot Number | MYBWRC14 |
| 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 |