MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-29 for JAMSHIDI TIN3015 manufactured by Carefusion 2200, Inc.
[96035721]
Patient Sequence No: 1, Text Type: N, H10
[96035722]
Patient was undergoing a bone marrow biopsy. Reportedly, during the procedure, while attempting to get the aspirate, the practitioner removed the introducer and the handle broke off. No reported patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7154166 |
| MDR Report Key | 7154166 |
| Date Received | 2017-12-29 |
| Date of Report | 2017-12-06 |
| Date of Event | 2017-11-29 |
| Report Date | 2017-12-06 |
| Date Reported to FDA | 2017-12-06 |
| Date Reported to Mfgr | 2017-12-06 |
| Date Added to Maude | 2017-12-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAMSHIDI |
| Generic Name | BONE MARROW COLLECTION/TRANSFUSION KIT |
| Product Code | LWE |
| Date Received | 2017-12-29 |
| Model Number | TIN3015 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 2200, INC |
| Manufacturer Address | 400 EAST FOSTER RD. MANNFORD OK 74044 US 74044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-29 |