MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-11-12 for JAMSHIDI NEEDLE BONE MARROW 8GX4 ASP DJ4008X manufactured by Carefusion.
[18312412]
During a? Bone marrow biopsy procedure, when a? Physician took tissue from the biopsy needle, a metal piece came out with the tissue? From the needle. The metal piece was taken by forceps from the formalin solution. The metal piece will be sent with the sample. There was no injury or medical intervention required. On (b)(6) 2013, the international contact ((b)(4)) provided the following additional information as obtained from the end user:? There was nothing noticed of the needle prior to use that would indicate a defect and there? Was no defect noted of the needle after the biopsy was taken. The biopsy procedure? Was not difficult in any way and the bone was not harder or more rigid? Than the physician expected. Also,? The physician did not feel? He needed to place a lot of force on the needle when repositioning to severe the sample as instructed in the product? S instructions for use.
Patient Sequence No: 1, Text Type: D, B5
[18433860]
(b)(4). Upon completion of the investigation, a follow-up medwatch report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680904-2013-00015 |
| MDR Report Key | 3459857 |
| Report Source | 01,07 |
| Date Received | 2013-11-12 |
| Date of Report | 2013-10-10 |
| Date of Event | 2013-09-27 |
| Date Mfgr Received | 2013-10-10 |
| Date Added to Maude | 2014-02-19 |
| 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 | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| 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 8GX4 ASP |
| Generic Name | TRAY, SURGICAL, NEEDLE |
| Product Code | FSH |
| Date Received | 2013-11-12 |
| Returned To Mfg | 2013-10-15 |
| Model Number | DJ4008X |
| Lot Number | 0000451896 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-12 |