MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-16 for MONOJET BONE MARROW BIOPSY/ASPIRATION NEEDLE J TYPE manufactured by Covidien.
[33958730]
During a bone biopsy procedure, the device handle broke off. The exposed portion of the needle was removed with pliers. No adverse patient outcome occurred related to this incident. Diagnosis or reason for use: anal cancer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058598 |
| MDR Report Key | 5311418 |
| Date Received | 2015-12-16 |
| Date of Report | 2015-12-02 |
| Date of Event | 2015-11-20 |
| Date Added to Maude | 2015-12-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 0 |
| Brand Name | MONOJET BONE MARROW BIOPSY/ASPIRATION NEEDLE J TYPE |
| Generic Name | ASPIRATION NEEDLE |
| Product Code | GDM |
| Date Received | 2015-12-16 |
| Lot Number | 143530348X |
| ID Number | K577292913010111 |
| Device Expiration Date | 2019-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | MANSFIELD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-16 |