MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,user facility report with the FDA on 2017-09-20 for OSTEO-SITE BONE BIOPSY NEEDLE N/A DBBN-11-10.0-M2-S manufactured by Cook Inc.
[86868503]
(b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[86868504]
The customer reported that, while the operator of the osteo-site bone biopsy needle was performing a bone marrow biopsy, the trocar of the device would not fit into the specimen needle to get the biopsy contents out. The operator reportedly had good needle placement in the patient's left tuberosity, but when the component of the device that is used to obtain the specimen was pulled out and the other trocar was inserted to push specimen out, it would not proceed. The operator believed this to be device related manufacturing problem, and subsequently filed an incident report. The circumstances surrounding the usage and handling of the device are not known. The customer confirmed that no patient adverse events were reported as a result of the issue. The product was returned for evaluation; however, as of the date of this report, the investigation is still pending.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-02940 |
| MDR Report Key | 6878537 |
| Report Source | CONSUMER,USER FACILITY |
| Date Received | 2017-09-20 |
| Date of Report | 2017-11-10 |
| Date Mfgr Received | 2017-11-27 |
| Device Manufacturer Date | 2016-12-01 |
| Date Added to Maude | 2017-09-20 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| 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 | 2017-09-20 |
| Model Number | N/A |
| Catalog Number | DBBN-11-10.0-M2-S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-09-20 |