MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-01-17 for OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE 17860061 manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
[15191729]
It was reported that the physician inserted the needle into l 5/s 1. The handgrip was attached to the cannula and the device was advanced into the pt. After the cannula reached the lesion, the syringe was attached to the cannula and a tissue sample was collected. After that, the physician attempted to pull out the cannula. The connection part of the hub and the proximal part of the needle was broken. At that time, the rest of the needle remained in the pt, but could be removed with "nippers. " the needle broke into two pieces. Both pieces were removed from the pt.
Patient Sequence No: 1, Text Type: D, B5
[15751806]
The investigation is currently underway.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681442-2012-00007 |
| MDR Report Key | 2425102 |
| Report Source | 01,06 |
| Date Received | 2012-01-17 |
| Date of Report | 2011-12-20 |
| Date of Event | 2011-12-13 |
| Date Mfgr Received | 2011-12-20 |
| Date Added to Maude | 2012-08-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DENISE YOUNG |
| Manufacturer Street | 1625 W. 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4808949515 |
| Manufacturer G1 | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG |
| Manufacturer Street | WACHHAUSSTRASSE 6 |
| Manufacturer City | KARLSRUHE 76227 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSTYCUT DISPOSABLE BONE BIOPSY NEEDLE |
| Product Code | DWO |
| Date Received | 2012-01-17 |
| Returned To Mfg | 2011-12-30 |
| Catalog Number | 17860061 |
| Lot Number | ANVE1572 |
| Device Expiration Date | 2014-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG |
| Manufacturer Address | KARLSRUHE GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-17 |