MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-03-25 for JAMSHIDI (TJ) BONE MARROW TRAY 11GX4 MAC BCTM3411 manufactured by Carefusion.
[1293227]
Customer stated, "the oncologist hematologist states that it is difficult to release the bone marrow after she has extracted it from the bone marrow. In one bone marrow procedure, the doctor stuck herself with the needle attempting to get the bone marrow out for the lab. "
Patient Sequence No: 1, Text Type: D, B5
[8540519]
A complaint sample was not provided for eval; therefore, we are unable to determine the exact cause for the issue reported. A lot number was not reported; therefore, a device history review could not be performed. Improvements to this product have been made to the mfg process of the biopsy needle to minimize the reoccurrence of the super retention failure mode. These improvements included a narrowing of certain mfg specifications with regards to the grinding and forming operation of the needle. Since a lot number was not provided, we are unable to determine if this device was produced with these product improvements. A review of applicable mfg procedures did not identify any issues with the current mfg process that may have contributed to the reported failure mode.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625685-2010-00007 |
| MDR Report Key | 1646651 |
| Report Source | 05,06 |
| Date Received | 2010-03-25 |
| Date of Report | 2010-03-23 |
| Date of Event | 2010-01-12 |
| Date Mfgr Received | 2010-03-04 |
| Date Added to Maude | 2010-04-01 |
| 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 | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN RD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | CAREFUSION |
| Manufacturer City | MANNFORD OK |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAMSHIDI (TJ) BONE MARROW TRAY 11GX4 MAC |
| Generic Name | JAMSHIDI (TJ) BONE MARROW TRAY 11GX4 MAC |
| Product Code | LWE |
| Date Received | 2010-03-25 |
| Model Number | BCTM3411 |
| Catalog Number | BCTM3411 |
| Lot Number | NO LOT GIVEN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-03-25 |