MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-11 for JAMSHIDI ASPIRATION NEEDLE manufactured by Carefusion.
[3938556]
During bone marrow biopsy, jamshidi aspiration needle broke in half. Part of needle remained in pt's iliac crest and required surgical removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5032738 |
| MDR Report Key | 3469676 |
| Date Received | 2013-11-11 |
| Date of Report | 2013-11-08 |
| Date of Event | 2013-11-06 |
| Date Added to Maude | 2013-11-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAMSHIDI ASPIRATION NEEDLE |
| Generic Name | ASPIRATION NEEDLE |
| Product Code | LWE |
| Date Received | 2013-11-11 |
| Lot Number | 0000535128 |
| Device Expiration Date | 2018-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2013-11-11 |