MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-03-25 for BARDEX? I.C. TEMPERATURE SENSING FOLEY CATHETER 129414M manufactured by C.r. Bard, Inc. (covington) -1018233.
[186525208]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[186525209]
It was reported that the catheter balloon was difficult to deflate on the 2nd day after placement. The catheter balloon was burst with a guidewire while using ultrasonic imaging. Per additional information from the ibc via email 10mar2020, it was confirmed that the catheter balloon was not burst with a guidewire, but with percutaneous puncture while using ultrasonic imaging. Per additional information from the ibc via email 17mar2020, there were no missing pieces to the burst balloon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-02094 |
| MDR Report Key | 9878844 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-25 |
| 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 | FOLEY CATHETER (LATEX) |
| Product Code | MJC |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-20 |
| Catalog Number | 129414M |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-25 |