MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-01-07 for JAMSHIDI * BAK4511 manufactured by Cardinal Health.
[1273392]
The physician was attempting to pull biopsy needle out after bone core samples were taken and the biopsy needle broke off. A fragment of the needle was left in the patient. Both physicians consulted and came to agreement to leave the needle. The parents of the patient were notified. Manufacturer response (as per reporter) for bone marrow aspiration needle, jamshidi:she will come in and look at the broken device, maybe take photos.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1580417 |
| MDR Report Key | 1580417 |
| Date Received | 2010-01-07 |
| Date of Report | 2010-01-07 |
| Date of Event | 2009-12-02 |
| Report Date | 2010-01-07 |
| Date Reported to FDA | 2010-01-07 |
| Date Added to Maude | 2010-01-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAMSHIDI |
| Generic Name | BONE MARROW ASPIRATION NEEDLE |
| Product Code | LWE |
| Date Received | 2010-01-07 |
| Model Number | * |
| Catalog Number | BAK4511 |
| Lot Number | L9J293 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 4551 E PHILADELPHIA ST ONTARIO CA 92881 US 92881 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-01-07 |