MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-06-29 for OSTEO-SITE BONE BIOPSY NEEDLE DBBN-13-15.0-M2 manufactured by Cook Inc.
[112702533]
(b)(4). Pma/510(k) #: exempt. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[112702534]
It was reported while performing a bone biopsy, one of the prongs of the osteo-site bone biopsy needle broke-off after sampling. The device fragment was retained by the patient and it is unknown if plans have been made to retrieve it. To date, additional information regarding the event and patient have not been made available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01848 |
| MDR Report Key | 7649730 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-06-29 |
| Date of Report | 2018-10-02 |
| Report Date | 2018-06-11 |
| Date Reported to Mfgr | 2018-06-11 |
| Date Mfgr Received | 2018-09-17 |
| Device Manufacturer Date | 2017-11-14 |
| Date Added to Maude | 2018-06-29 |
| 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 |
| Reporter Occupation | OTHER CAREGIVERS |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC. |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSTEO-SITE BONE BIOPSY NEEDLE |
| Generic Name | DWO NEEDLE, BIOPSY, CARDIOVASCULAR |
| Product Code | DWO |
| Date Received | 2018-06-29 |
| Catalog Number | DBBN-13-15.0-M2 |
| Lot Number | 8373605 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-29 |