MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2015-03-20 for JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP DJ4011X manufactured by Carefusion.
[5700743]
During a biopsy, the needle is broken and a part is still in the patient. Need for surgical intervention for extraction. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
[13102842]
(b)(4): if further information becomes available a follow up medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[25808183]
(b)(4): failure mode could not be confirmed because samples were not received for evaluation. 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. Based on the investigation results, a definitive root cause could not be identified for the reported failure mode since samples were not returned for analysis. The issue will continue to be tracked and trended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680904-2015-00054 |
| MDR Report Key | 4619542 |
| Report Source | 01 |
| Date Received | 2015-03-20 |
| Date of Report | 2015-04-20 |
| Date of Event | 2015-02-06 |
| Date Mfgr Received | 2015-02-23 |
| Date Added to Maude | 2015-03-20 |
| 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 11GX4 ASP |
| Generic Name | TRAY, SURGICAL, NEEDLE |
| Product Code | FSH |
| Date Received | 2015-03-20 |
| Model Number | DJ4011X |
| Lot Number | 0000602145 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Hospitalization | 2015-03-20 |