MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-03-14 for BONE MARROW NEEDLE (J TYPE) IMKBMN-13R-10 NA manufactured by Manan Medical Products, Inc., Dba Angiotech.
[2628759]
This report was received from our oem customer in (b)(6): a fourth year resident used a 13g x 10cm bone marrow biopsy needle for bone marrow acquisition in the pt's pelvis. When trying to remove the needle, the physician felt the needle stick and difficult to remove because the pt's bone was too hard for 13g needle. After several attempts, the physician pulled and waved the needle a bit, which ultimately caused a severance of the needle. The resident physician had to make an incision to remove the cut-off needle from the pt. The severed piece of needle was removed without any further problem. The pt feels fine except for removal incision. Incident occurred at (b)(6) hospital.
Patient Sequence No: 1, Text Type: D, B5
[9767825]
The bone needle was used in a (b)(6) pt. Three retained samples from the lot involved in the event were evaluated and met specs. The reporter stated the device performed as intended and the event occurred during device removal. The device in question was not returned for eval. The procedure was performed in the ilium. The reporter stated the doctor did not rotate the device right and left; instead, the doctor pulled with strength when resistance was felt and the needle could not be removed easily. The cannula is designed to be rotated back and forth and works optimally when using this motion rather than pulling or waving the needle. The reporter also stated the physician used a 13g needle when an 11g would have been optimal.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417485-2012-00001 |
| MDR Report Key | 2496241 |
| Report Source | 06,07 |
| Date Received | 2012-03-14 |
| Date of Report | 2012-02-27 |
| Date of Event | 2012-02-23 |
| Date Mfgr Received | 2012-02-27 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2012-03-21 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JIM AWERKAMP, MGR |
| Manufacturer Street | 241 WEST PALATINE RD. |
| Manufacturer City | WHEELING IL 60090 |
| Manufacturer Country | US |
| Manufacturer Postal | 60090 |
| Manufacturer Phone | 2246258331 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE MARROW NEEDLE (J TYPE) |
| Generic Name | BONE MARROW BIOPSY NEEDLE |
| Product Code | DWO |
| Date Received | 2012-03-14 |
| Model Number | IMKBMN-13R-10 |
| Catalog Number | NA |
| Lot Number | EH62 |
| ID Number | 8120-13R-10 |
| Device Expiration Date | 2016-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MANAN MEDICAL PRODUCTS, INC., DBA ANGIOTECH |
| Manufacturer Address | 241 WEST PALATINE RD. WHEELING IL 60090 US 60090 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-03-14 |