MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-27 for ONCONTROL COAXIAL BIOPSY TRAY 11/13 GA 9464-VC-006 manufactured by Teleflex Medical.
[181162750]
(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[181162751]
It was reported that the patient was on the table and the needle was stuck in the bone and they could not get it out. The account ended up getting ortho to come out and get the needle out. Additional information from the physician indicates the patient suffered no adverse effects from the broken needle. We were able to have the orthopedic surgeon assist us during the procedure and bore out the bone around the broken oncontrol needle using a larger orthopedic drill. The needle came out easily. The bone lesion being biopsied was in the l iliac bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2020-00074 |
| MDR Report Key | 9763790 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-02-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONCONTROL COAXIAL BIOPSY TRAY 11/13 GA |
| Generic Name | BIOPSY NEEDLE KIT |
| Product Code | FCG |
| Date Received | 2020-02-27 |
| Catalog Number | 9464-VC-006 |
| Lot Number | 37581316 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | ATHLONE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-27 |