MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-22 for SPINAL NEEDLE 4324ADF manufactured by Carefusion.
[142955467]
Pt was in the process of receiving a myelogram. During one of the attempts at access, the outer portion of the spinal needle became dislodged from the hub and embedded in the soft tissue and required subsequent retrieval. As such, further attempts at access were not performed. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086070 |
| MDR Report Key | 8541229 |
| Date Received | 2019-04-22 |
| Date of Report | 2019-04-18 |
| Date of Event | 2019-04-11 |
| Date Added to Maude | 2019-04-23 |
| 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 | 0 |
| Brand Name | SPINAL NEEDLE |
| Generic Name | NEEDLE, SPINAL, SHORT TERM |
| Product Code | MIA |
| Date Received | 2019-04-22 |
| Model Number | 4324ADF |
| Catalog Number | 4324ADF |
| Lot Number | 0000718010 |
| Device Expiration Date | 2019-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-22 |