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 2020-03-23 for BARDEX? I.C. TEMPERATURE SENSING FOLEY CATHETER 129414M manufactured by C.r. Bard, Inc. (covington) -1018233.
[187857679]
The device was not returned for evaluation. 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:? [contraindications] method for use: do not reuse. Do not resterilize. 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. Patients who are or have been allergic to natural rubber latex. Patients with known allergy to silver coated catheter. [directions for use]. To deflate balloon and remove catheter, insert a luer tip (needleless) syringe in the inflation valve to allow the water to drain spontaneously. After balloon deflation, withdraw the catheter while confirming that no resistance is encountered. "
Patient Sequence No: 1, Text Type: N, H10
[187857680]
It was reported that it was difficult to deflate the balloon of the catheter. The doctor tried to insert a guidewire into the inflation lumen to burst balloon, however the balloon remained inflated. The balloon deflated the next day of the placement, and the catheter was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-02033 |
| MDR Report Key | 9868295 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-23 |
| 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. TEMPERATURE SENSING FOLEY CATHETER |
| Generic Name | TEMPERATURE SENSING CATHETER (SILICON) |
| Product Code | MJC |
| Date Received | 2020-03-23 |
| Catalog Number | 129414M |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2020-03-23 |