MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-08-17 for JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP DJ4011X manufactured by Carefusion.
[2802703]
Customer reported that during biopsy, the needle broke in patient's r iliac crest. The bone was reported to be more dense than usual. The orthopedic surgeon had to be called in to perform a secondary procedure to remove the piece of the jamshidi needle from the iliac crest and the needle and the broken piece were both discarded. The piece was removed successfully and no patient injury was reported. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[10226010]
(b)(4): the sample was reported by the customer to be discarded, therefore a sample evaluation cannot be performed. A follow up medwatch will be submitted upon completion of carefusion's investigation.
Patient Sequence No: 1, Text Type: N, H10
[21358019]
(b)(4): a definitive root cause could not be determined, since samples were not received for evaluation. During review of the applicable manufacturing, inspection, and packaging processes, no issues were found that could relate personnel or processes to the reported condition. The manufacturing procedure does call out to verify the needle condition prior to passing needles to the next stage. However an update will be performed to the manufacturing procedure to specifically include an inspection for a broken or damaged needle. All applicable manufacturing and quality personnel will be notified of this failure mode in an effort to heighten awareness.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680904-2012-00044 |
| MDR Report Key | 2705029 |
| Report Source | 00 |
| Date Received | 2012-08-17 |
| Date of Report | 2012-07-27 |
| Date of Event | 2012-07-23 |
| Date Mfgr Received | 2012-11-16 |
| Date Added to Maude | 2012-12-05 |
| 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 | JILL RITTORNO |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8474737294 |
| Manufacturer G1 | CAREFUSION 203 LTD |
| Manufacturer Street | ZONA FRANCA LAS AMERICAS KM 22 E-1 |
| 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 | 2012-08-17 |
| Model Number | DJ4011X |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 1500 WAUKEGAN RD MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-17 |