MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-03-19 for BARDEX? LUBRICATH? FOLEY CATHETER 0165L16 manufactured by C.r. Bard, Inc. (covington) -1018233.
[184130413]
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)/mechanical failure/operator error/thin rubberize layer) 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: "[warnings] method for use: do not inflate the balloon in the urethra. [the urethra may be injured. ]do not pull the catheter hard. [the bladder/urethra may be injured. ] applicable patients: patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged. ] [contraindications] method for use: do not reuse. Do not resterilize. This device contains 10% povidone-iodine. For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants. Be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils). [they may damage the device and may burst balloon. ] do not hold the device with forceps, etc. Avoid contact with any blades or sharp-edged instruments. [catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon. ] applicable patients: do not use in patients who are or have been allergic to natural rubber latex. "
Patient Sequence No: 1, Text Type: N, H10
[184130494]
It was reported that the catheter fell out of the patient with a deflated balloon due to water leakage on the 7th day of placement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01932 |
| MDR Report Key | 9853544 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-26 |
| 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 |
| 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 | FOLEY CATHETER (LATEX) |
| Product Code | EZC |
| Date Received | 2020-03-19 |
| 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 | 2020-03-19 |