MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-02 for CARDINAL HEALTH HT31-BM2CO manufactured by Cardinal Health 200, Llc.
[90860183]
Patient Sequence No: 1, Text Type: N, H10
[90860184]
During bone biopsy needle from strl bm biopsy pr 11gx4 15gx5 kit bent. New needle had to be used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6995845 |
| MDR Report Key | 6995845 |
| Date Received | 2017-11-02 |
| Date of Report | 2017-10-24 |
| Date of Event | 2017-10-17 |
| Report Date | 2017-10-24 |
| Date Reported to FDA | 2017-10-24 |
| Date Reported to Mfgr | 2017-10-24 |
| Date Added to Maude | 2017-11-02 |
| 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 | 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 | CARDINAL HEALTH |
| Generic Name | NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE |
| Product Code | FSH |
| Date Received | 2017-11-02 |
| Model Number | HT31-BM2CO |
| Catalog Number | HT31-BM2CO |
| Lot Number | 397833 |
| ID Number | STRL BM BIOPSY PR 11GX4 15GX5 |
| Device Expiration Date | 2019-03-01 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 785 FORT MILL HWY. FORT MILL SC 29707 US 29707 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-02 |