MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-07 for JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP DJ4011X manufactured by Carefusion, Inc.
[67134272]
(b)(4) initial emdr submission. A follow up emdr will be submitted upon completion of investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[67134273]
Sales rep reported via email: the handle broke off the needle while the needle was in the patient's pelvis. We were able to get the needle out with vice grips and no harm was done to the patient.
Patient Sequence No: 1, Text Type: D, B5
[73687350]
(b)(4) follow up emdr for device evaluation. One (1) sample from lot #0000987427 was received for evaluation. During visual analysis failure mode could be confirmed since the handle was detached from the needle. A review of the internal manufacturing device record and raw material history files for the reported lot number was performed and no recorded quality problems or rejections related to this incident were found. It was confirmed that procedural and functional requirements needed for its release were met. ? Lot#0000987427 was manufactured on 01-sep-2016. Defective component: most probable cause of failure mode reported could be related with material provided from (b)(4). A scar (supplier corrective action request) was sent to the supplier ((b)(4)). This failure mode will be entered into the complaint tracking system and tracked & trended for future occurrences of any similar failure modes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680904-2017-00099 |
| MDR Report Key | 6307076 |
| Date Received | 2017-02-07 |
| Date of Report | 2017-04-05 |
| Date of Event | 2017-01-27 |
| Date Mfgr Received | 2017-01-27 |
| Date Added to Maude | 2017-02-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | ZONA FRANCA LAS AMERICAS |
| Manufacturer City | SANTO DOMINGO |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP |
| Generic Name | TRAY, SURGICAL, NEEDLE |
| Product Code | FSH |
| Date Received | 2017-02-07 |
| Returned To Mfg | 2017-02-03 |
| Model Number | DJ4011X |
| Lot Number | 0000987427 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-07 |