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 2020-03-14 for BARD? FOLEY CATHETER SILICONE COATED 265716 manufactured by C.r. Bard, Inc. (covington) -1018233.
[183472783]
The device was not returned for evaluation. A the potential root cause for this failure mode could be bad fit with shaft/ no drainage eye/ poorly seated balloon/ bladder neck interface. 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:? Caution: this product contains natural rubber latex which may cause allergic reactions. Pk6194321 4/03 rev. 0 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 a petrolatum base. They will damage latex and may cause balloon burst. Visually inspect the product for any imperfections or surface deterioration prior to use. Recommended inflation capacities 3cc balloon: use 5cc sterile water 5cc balloon: use 10cc sterile water 15cc balloon: use 20cc sterile water 20cc balloon: use 25cc sterile water 30cc balloon: use 35cc sterile water 40cc balloon: use 45cc sterile water 75cc balloon: use 50cc sterile water do not exceeded recommended capacities. "
Patient Sequence No: 1, Text Type: N, H10
[183472784]
It was reported that the 5cc balloon was too small. The patient experienced leakage from the meatus due to this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01830 |
| MDR Report Key | 9832818 |
| Report Source | CONSUMER,DISTRIBUTOR,OTHER |
| Date Received | 2020-03-14 |
| Date of Report | 2020-03-13 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-14 |
| 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 | BARD? FOLEY CATHETER SILICONE COATED |
| Generic Name | SILICONE FOLEY |
| Product Code | EZC |
| Date Received | 2020-03-14 |
| Model Number | 265716 |
| Catalog Number | 265716 |
| 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 | 2020-03-14 |