MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-12-22 for JAMSHIDI BONE MARROW BIOPSY/ASPIRATION TRAY EJT4511 manufactured by Allegiance Healthcare.
[112591]
The handle broke off of the needle while it was in the pt's bone. There were no pt injury as a result of the event. The intact needle was removed from the pt's bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-1997-00284 |
| MDR Report Key | 139456 |
| Report Source | 05,06 |
| Date Received | 1997-12-22 |
| Date of Report | 1997-12-22 |
| Date of Event | 1997-11-26 |
| Date Mfgr Received | 1997-12-02 |
| Device Manufacturer Date | 1997-06-01 |
| Date Added to Maude | 1997-12-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAMSHIDI BONE MARROW BIOPSY/ASPIRATION TRAY |
| Generic Name | NEEDLE |
| Product Code | LWE |
| Date Received | 1997-12-22 |
| Model Number | EJT4511 |
| Catalog Number | EJT4511 |
| Lot Number | L7H033 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 136165 |
| Manufacturer | ALLEGIANCE HEALTHCARE |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | JAMSHIDI BONE MARROW BIOPSY/ASPIRATION TRAY |
| Baseline Generic Name | NEEDLE |
| Baseline Model No | EJT4511 |
| Baseline Catalog No | EJT4511 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-12-22 |