MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-03 for JAMSHIDI BONE MARROW PROCEDURE TRAY EJT4511 * manufactured by Baxter Health Care Corp..
[25176]
During a bone marrow biopsy procedure the catheter broke off at the handle. Pt went to the operating room for removal of foreign body from the iliac crest. The md states that when he turned the handle during the biopsy, the handle became stripped from the catheter. The handle would turn but not the needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 35774 |
| MDR Report Key | 35774 |
| Date Received | 1996-07-03 |
| Date of Report | 1996-03-15 |
| Date of Event | 1996-01-31 |
| Date Facility Aware | 1996-02-01 |
| Report Date | 1996-03-15 |
| Date Reported to FDA | 1996-03-18 |
| Date Reported to Mfgr | 1996-03-18 |
| Date Added to Maude | 1996-08-26 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 BONE MARROW PROCEDURE TRAY |
| Generic Name | BONE MARROW ASPIRATION NEEDLE/KIT & JAMSHIDI NEEDLE |
| Product Code | LWE |
| Date Received | 1996-07-03 |
| Model Number | EJT4511 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 37200 |
| Manufacturer | BAXTER HEALTH CARE CORP. |
| Manufacturer Address | 1500 WAUKEGAN RD MCGAW PARK IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-07-03 |