MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-04-08 for OSTEO-SITE BONE BIOPSY NEEDLE DBBN-11-10.0-M2 manufactured by Cook Inc.
[42212363]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[42212364]
As indicated in the maude database under report number (b)(4): during an unknown procedure on a patient of unknown age and gender, the patient was prone on the table and was prepped and draped in the usual manner. Aspiration and core biopsies were obtained using the cook bone biopsy needle 11. 0-10. 0-m2. The bone was exceedingly hard requiring a greater than usual amount of effort to obtain the marrow specimen. This resulted in one tine of the needle breaking off and being left behind in the bone.
Patient Sequence No: 1, Text Type: D, B5
[46785133]
(b)(4). Investigation / evaluation: no images or device were returned; however, during the course of the investigation, a review of the complaint history, instructions for use (ifu), quality control and trends was conducted. There is no evidence to suggest the product was not manufactured to current specifications. The root cause was determined to be device encountered forces beyond its intended design. Per the quality engineering risk assessment, no further action is required. We will continue to monitor for similar complaints, and have notified the appropriate internal personnel of this event.
Patient Sequence No: 1, Text Type: N, H10
[46785134]
As indicated in the maude database under report number (b)(4): during an unknown procedure on a patient of unknown age and gender, the patient was prone on the table and was prepped and draped in the usual manner. Aspiration and core biopsies were obtained using the cook bone biopsy needle 11. 0-10. 0-m2. The bone was exceedingly hard requiring a greater than usual amount of effort to obtain the marrow specimen. This resulted in one tine of the needle breaking off and being left behind in the bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2016-00226 |
| MDR Report Key | 5563991 |
| Report Source | OTHER |
| Date Received | 2016-04-08 |
| Date of Report | 2016-03-17 |
| Date of Event | 2015-08-25 |
| Date Facility Aware | 2015-08-25 |
| Report Date | 2015-09-22 |
| Date Reported to FDA | 2015-09-22 |
| Date Mfgr Received | 2016-03-22 |
| Date Added to Maude | 2016-04-08 |
| 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 | MRS. RITA HARDEN |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| 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 | 2016-04-08 |
| Model Number | NA |
| Catalog Number | DBBN-11-10.0-M2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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. Other | 2016-04-08 |