MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-16 for N/A 4541 manufactured by Carefusion 2200, Inc.
[105538273]
Patient Sequence No: 1, Text Type: N, H10
[105538274]
Pudendal tray syringe broke during procedure. Per physician's report, this is the third syringe that has broken in this fashion that she is aware of recently. When plunger is pressed the piece holding the pistol grip in place broke. Photos attached to this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7432480 |
| MDR Report Key | 7432480 |
| Date Received | 2018-04-16 |
| Date of Report | 2018-03-30 |
| Date of Event | 2018-03-20 |
| Report Date | 2018-03-30 |
| Date Reported to FDA | 2018-03-30 |
| Date Reported to Mfgr | 2018-03-30 |
| Date Added to Maude | 2018-04-16 |
| 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 |
| 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 | SET, ANESTHESIA, PARACERVICAL |
| Product Code | HEE |
| Date Received | 2018-04-16 |
| Model Number | 4541 |
| Catalog Number | 4541 |
| Lot Number | 0000967173 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 2200, INC |
| Manufacturer Address | 400 EAST FOSTER RD. MANNFORD OK 74044 US 74044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-16 |