MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-03-04 for PERCUCUT BIOPSY NEEDLE N 905 manufactured by E-z-em, Inc..
[26651]
During needle biopsy of right lung as physician was obtaining specimen, needle broke off from hub. Needle was still in pt's lung. Physician tried to get needle without hemastat but was not able to locate needle. Pt was taken from ct room to remove per cart. Under fluoro, physician was able to locate needle and remove needle from lung using a hemastat and fluoro. Box was then obtained with different needle. Pt was transferred to room per cart. Pt's condition remained stable throughout procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 31883 |
| MDR Report Key | 31883 |
| Date Received | 1996-03-04 |
| Date of Report | 1996-02-23 |
| Date of Event | 1996-02-22 |
| Date Added to Maude | 1996-04-10 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | PERCUCUT BIOPSY NEEDLE |
| Generic Name | BIOPSY NEEDLE |
| Product Code | MJG |
| Date Received | 1996-03-04 |
| Catalog Number | N 905 |
| Lot Number | 8102FL |
| Device Expiration Date | 1999-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 33023 |
| Manufacturer | E-Z-EM, INC. |
| Manufacturer Address | WESTBURY NY 115905021 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-03-04 |