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.
[188206534]
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
[188206535]
It was reported that the catheter balloon was difficult to deflate on the second day of use. It was stated that they tried to pump the syringe and cut the inflation lumen and then the catheter shaft, but the water would not come out. Next a guidewire was used to try and clear the lumen and then to try to burst the balloon, but it did not work either. Last, the water was able to be removed by the urologist. The original sample was discarded, however 6 lot samples were to be sent in for testing. Per additional information from the ibc via email 11mar2020, the urologist used percutaneous puncture and there were no missing pieces to the burst balloon. No additional medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-02102 |
| MDR Report Key | 9880116 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-01 |
| 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 | MYDV3402 |
| 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 |