MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-16 for N/A 006172P manufactured by C. R. Bard, Inc..
[175219606]
At a minimum of 5 times since the end of 2017, providers who have been using the "bard medical temporary pacing electrode catheter" have had instances of the tip of the catheter puncturing the wall of the heart, causing cases of pericardial effusion. In none of these instances did staff keep any of the packaging or any piece of the cardiac catheter kit. Providers requested a new type of catheter device, and when they began using it, the problems subsided. The new catheter kits that they were using eventually ran out of stock, causing them to go back and use the original ones that were originally causing problems for patients. At the end of 2019, after switching back to the bard medical catheters, a provider had another problem with a "bard medical temporary pacing electrode catheter. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9595638 |
| MDR Report Key | 9595638 |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-12-03 |
| Report Date | 2020-01-06 |
| Date Reported to FDA | 2020-01-06 |
| Date Reported to Mfgr | 2020-01-16 |
| Date Added to Maude | 2020-01-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N/A |
| Generic Name | ELECTRODE, PACEMAKER, TEMPORARY |
| Product Code | LDF |
| Date Received | 2020-01-16 |
| Model Number | 006172P |
| Catalog Number | 006172P |
| Lot Number | GFDW3504 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C. R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL DRIVE COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-16 |