MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-30 for JAMSHIDI BONE MARROW BIOPSY & ASPIRATION TRAY (BAK4511) BAK 4511 manufactured by Carefusion / Bd.
[125913209]
After making the incision, the physician was holding pressure on the pt. With his left hand and single-handedly (rt hand) picked up the blade cover using the scalpel blade. While securing the blade cover with his left hand, the blade's tip caught on the plastic ribbing inside the cover. It pierced through the cover and cut the dr's index finger (left). Kits used > 10 yr; single use kits. Bone marrow asp and bx on pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080952 |
| MDR Report Key | 8023733 |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-19 |
| Date of Event | 2018-10-18 |
| Date Added to Maude | 2018-10-31 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | JAMSHIDI BONE MARROW BIOPSY & ASPIRATION TRAY (BAK4511) |
| Generic Name | TRAY, SURGICAL, NEEDLE |
| Product Code | FSH |
| Date Received | 2018-10-30 |
| Catalog Number | BAK 4511 |
| Lot Number | 0001256716 |
| Device Expiration Date | 2019-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION / BD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-30 |