MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-01 for FLEXI-GUIDE NEEDLE, 15.5G X 25CM (25PC) 0912 manufactured by Mick Radio-nuclear Instruments, Inc.
[134713670]
Catheter needle tip for brachy therapy - doctor states "(plastic) tip of catheter broke off, but i saw that it did not go in the patient, but i cannot find it". No x-ray obtained as tip is plastic, per doctor. Upon review, or circulator called soon after, indicated the tip was found in gel outside patient prior to leaving the operating room (or).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8296216 |
| MDR Report Key | 8296216 |
| Date Received | 2019-02-01 |
| Date of Report | 2019-01-31 |
| Date of Event | 2019-01-22 |
| Report Date | 2019-01-31 |
| Date Reported to FDA | 2019-01-31 |
| Date Reported to Mfgr | 2019-02-01 |
| Date Added to Maude | 2019-02-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | FLEXI-GUIDE NEEDLE, 15.5G X 25CM (25PC) |
| Generic Name | SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED |
| Product Code | JAQ |
| Date Received | 2019-02-01 |
| Model Number | 0912 |
| Catalog Number | 0912 |
| Lot Number | 170307-82 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICK RADIO-NUCLEAR INSTRUMENTS, INC |
| Manufacturer Address | 521 HOMESTEAD AVENUE MOUNT VERNON NY 10550 US 10550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-01 |