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.
[188328803]
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
[188328807]
It was reported that the catheter balloon was difficult to deflate on the day after placement. When the water would not come out using the normal procedures, the user attempted to pull the water out with the syringe. The inflation lumen was cut but no water came out, and the urologist cleared the lumen by using a guidewire. Per additional information from the ibc via email 17mar2020, the balloon was still intact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-02090 |
| MDR Report Key | 9878644 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-03 |
| 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 |