MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for PIGTAIL CATHETER manufactured by Bard / C. R. Bard, Inc..
[175493377]
Pt had pigtail catheter inserted for perforated appendicitis. Two days following insertion the pigtail external plastic cup was noted to be cracked. The pt required replacement of the pigtail catheter via interventional radiology. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092235 |
| MDR Report Key | 9591597 |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-10 |
| Date of Event | 2020-01-06 |
| Date Added to Maude | 2020-01-15 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | RISK MANAGER |
| 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 | PIGTAIL CATHETER |
| Generic Name | CATHETER, IRRIGATION |
| Product Code | GBX |
| Date Received | 2020-01-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD / C. R. BARD, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-14 |