MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-27 for SAFE-T PLUS 4325SP manufactured by Carefusion 2200, Inc.
[68377304]
The following elements have blank data.
Patient Sequence No: 1, Text Type: N, H10
[68377305]
During an arthrogram, contrast was noted to be leaking around the hub.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6360273 |
| MDR Report Key | 6360273 |
| Date Received | 2017-02-27 |
| Date of Report | 2017-01-30 |
| Date of Event | 2017-01-30 |
| Report Date | 2017-01-30 |
| Date Reported to FDA | 2017-01-30 |
| Date Reported to Mfgr | 2017-01-30 |
| Date Added to Maude | 2017-02-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | SAFE-T PLUS |
| Generic Name | NEEDLE, SPINAL, SHORT TERM |
| Product Code | MIA |
| Date Received | 2017-02-27 |
| Catalog Number | 4325SP |
| Lot Number | 0001017433 |
| ID Number | LIDOCAINE VENDOR LOT #661853A |
| Device Expiration Date | 2019-05-31 |
| 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 | 2017-02-27 |