MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-26 for DISPOSABLE BONE MARROW BIOPSY/NEEDLE ASPIRATION BAK 3411 manufactured by Baxter Healthcare Corp..
[18632]
Bone marrow biopsy needle broke on removal from bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 33084 |
| MDR Report Key | 33084 |
| Date Received | 1996-04-26 |
| Date of Report | 1996-04-23 |
| Date of Event | 1996-04-15 |
| Date Facility Aware | 1996-04-15 |
| Report Date | 1996-04-23 |
| Date Reported to FDA | 1996-04-23 |
| Date Added to Maude | 1996-05-23 |
| 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 | DISPOSABLE BONE MARROW BIOPSY/NEEDLE ASPIRATION |
| Generic Name | BONE MARROW BIOPSY/NEEDLE ASPIRATION |
| Product Code | MJG |
| Date Received | 1996-04-26 |
| Catalog Number | BAK 3411 |
| Lot Number | L5N085 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 34403 |
| Manufacturer | BAXTER HEALTHCARE CORP. |
| Manufacturer Address | DEERFIELD IL 60015 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-04-26 |