MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2013-10-16 for OSTEO-SITE BONE BIOPSY NEEDLE DBBN-13-15.0-M2 manufactured by Cook Inc.
[18298733]
The device was used for bone biopsy. When the physician turned the cannula after advancing it to the lumbar vertebra, tip of the cannula got damaged and separated. Then, another device was used instead to complete the procedure. Simple x-ray test and ct confirmed that there was no section of the cannula remained in the pt body. The separated section was eliminated from the body in some unk way during the procedure. The pt has a favorable outcome.
Patient Sequence No: 1, Text Type: D, B5
[18586153]
(b)(4). Each device is inspected to verify that the product matches the work order, specifications, and product label. All devices are examined to ensure that the correct bevels are on the stylets and proper alignment between cannula and stylet. An examination of the returned product confirms one of the tips on the cannula is missing. It is feasible to suggest the tip came off due to being turned while embedded with the bone. Root cause is inconclusive. We will continue to monitor for similar complaints. No additional actions required at this time. Per qera, additional action is not required at this time based on the associated risk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2013-00415 |
| MDR Report Key | 3435576 |
| Report Source | 01,08 |
| Date Received | 2013-10-16 |
| Date of Report | 2013-09-17 |
| Date of Event | 2013-08-23 |
| Date Facility Aware | 2013-08-23 |
| Report Date | 2013-09-17 |
| Date Mfgr Received | 2013-09-18 |
| Device Manufacturer Date | 2013-02-08 |
| Date Added to Maude | 2013-10-30 |
| 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 | RITA HARDEN, DIR. |
| 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 | GDM - NEEDLE, ASPIRATION AND INJECTION, REUSABLE |
| Product Code | GDM |
| Date Received | 2013-10-16 |
| Returned To Mfg | 2013-09-24 |
| Model Number | NA |
| Catalog Number | DBBN-13-15.0-M2 |
| Lot Number | F4031439 |
| ID Number | NA |
| Device Expiration Date | 2016-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-10-16 |