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 2020-03-18 for BARDEX? I.C. FOLEY CATHETER 0165SI30 manufactured by C.r. Bard, Inc. (covington) -1018233.
[184063498]
The reported event was inconclusive as no sample was returned for evaluation. A potential root cause for this failure mode could be user related (example: salt accumulation)/ block drainage lumen/ no drainage eye. 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: "sterile: unless package is opened or damaged. Do not use if package is opened or damaged. Warning: on catheter, do not use ointments or lubricants having petrolatum base. They will damage latex and may cause the balloon to burst. Caution: do not aspirate urine through drainage funnel wall. Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box. Visually inspect the product for any imperfections or surface deterioration prior to use. Valve type: use luer slip syringe. Do not use needle. Recommended inflation capacities: 3cc balloon: use 5cc sterile water 5cc balloon: use 10cc sterile water 30cc balloon: use 35cc sterile water 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. Allow the pressure within the balloon to force the plunger back and fill the syringe with water. 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. 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
[184063499]
It was reported that the catheter leaks when there is heavy urine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01901 |
| MDR Report Key | 9850310 |
| Report Source | CONSUMER,DISTRIBUTOR,OTHER |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-02-24 |
| 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 | BARDEX? I.C. FOLEY CATHETER |
| Generic Name | BARDEX FOLEY |
| Product Code | MJC |
| Date Received | 2020-03-18 |
| Model Number | 0165SI30 |
| Catalog Number | 0165SI30 |
| 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 | 2020-03-18 |