MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-20 for PUDENDAL BLOCK TRAY 4541 manufactured by Carefusion 2200, Inc..
[77939608]
Patient Sequence No: 1, Text Type: N, H10
[77939609]
Pudendal syringe (blue attachment) pistol drop was not attached properly to the syringe. This led to the needle moving every time aspiration was attempted trying to make sure there wasn't an intravascular placement of needle. The top piece of the pistol grip is missing. It was not in the packaging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6653064 |
| MDR Report Key | 6653064 |
| Date Received | 2017-06-20 |
| Date of Report | 2017-06-12 |
| Date of Event | 2017-06-03 |
| Report Date | 2017-06-07 |
| Date Reported to FDA | 2017-06-07 |
| Date Reported to Mfgr | 2017-06-07 |
| Date Added to Maude | 2017-06-20 |
| 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 | PATIENT |
| 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 | PUDENDAL BLOCK TRAY |
| Generic Name | SET, ANESTHESIA, PARACERVICAL |
| Product Code | HEE |
| Date Received | 2017-06-20 |
| Model Number | 4541 |
| Catalog Number | 4541 |
| Lot Number | 0000800489 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 0 YR |
| 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 | 2017-06-20 |