MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-12 for BARDEX? LUBRICATH? FOLEY CATHETER 0165L16 manufactured by C.r. Bard, Inc. (covington) -1018233.
[183165021]
The reported event was inconclusive, as the device was not returned for evaluation. However, a 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: "warning: do not use ointments or lubricants having a petrolatum base. They will damage latex. Visually inspect the product for any imperfections or surface deterioration prior to use. Use luer tip syringe to inflate with stated ml of sterile water or for pre-filled products, remove dip and squeeze reservoir to inflate with state ml of sterile water". The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[183165022]
It was reported that the patient alleged repeated urinary leaks and skin erythema when using the catheter brand. The catheter was removed and replaced with a new one.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01785 |
| MDR Report Key | 9825327 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-12 |
| 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 | PHARMACIST |
| 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? LUBRICATH? FOLEY CATHETER |
| Generic Name | BIOCATH |
| Product Code | EZC |
| Date Received | 2020-03-12 |
| Catalog Number | 0165L16 |
| Lot Number | UNK |
| 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 | 2020-03-12 |