MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-03-19 for BARDEX? FOLEY CATHETER SILICONE COATED 0167V18S manufactured by C.r. Bard, Inc. (covington) -1018233.
[184151014]
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 has been opened or damaged. Warning: do not use ointments or lubricants having a petroleum base. They will damage latex and may burst balloon. Do not aspirate urine through the drainage funnel wall. Single use only. Do not desterilize. For urological use only. Valve type: use luer slip syringe. Do not use needle. To deflate catheter balloon: gently insert a syringe in the catheter valve. Never use 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, preventing balloon deflation. If permitted by hospital protocol, the valve arm may be severed. If this fails, contact an adequately trained professional for assistance, as directed by hospital protocol. "
Patient Sequence No: 1, Text Type: N, H10
[184151015]
It was reported that the balloon could not be deflated during pretest.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01958 |
| MDR Report Key | 9856146 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-08-02 |
| Date Added to Maude | 2020-03-19 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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? FOLEY CATHETER SILICONE COATED |
| Generic Name | BARDIA FOLEY CATHETER |
| Product Code | KOD |
| Date Received | 2020-03-19 |
| Catalog Number | 0167V18S |
| Lot Number | MYDS5728 |
| 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 | 2020-03-19 |