MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-12-18 for JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP DJ4011X manufactured by Carefusion.
[5205596]
Medical specialties - fell apart.? Per? Nurse manager,? Patient was having a bone biopsy and physician felt something happen with needle and stopped procedure. The needle was not able to be extracted, orthopedic surgeon consulted patient and was not able to retrieve broken needle. The patient was seen by orthopedic surgeon, needle unable to be extracted from patient. Ct scan performed. Needle remains in patient? S hip. Patient followed by physician to monitor.
Patient Sequence No: 1, Text Type: D, B5
[12672760]
(b)(4) if further information become available a follow up medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[33302098]
(b)(4). Pictures of the actual unit were received. While analyzing the pictures, it was noticed that the needle was broken. Failure mode could be confirmed. A review of the internal manufacturing device record for the reported lot number was performed and it was confirmed that procedural and functional requirements needed for its release were met. Also, a review of the device? S components history record review was performed and no issues were found. It is not considered personnel could be related to failure mode reported since no issues were found during applicable manufacturing process and training records analysis that could relate personnel to the reported failure. No issues related to equipment/machine were found during the investigation that could relate it to the reported failure mode. During the investigation, a review of environment specifications, procedures and monitoring data did not find any issues that may have contributed to the reported failure mode. Most probable root cause could be related to material provided by the supplier. A supplier corrective action request has been opened regarding broken dj needle.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680904-2014-00047 |
| MDR Report Key | 4343735 |
| Report Source | 06,07 |
| Date Received | 2014-12-18 |
| Date of Report | 2015-02-09 |
| Date of Event | 2014-10-09 |
| Date Mfgr Received | 2014-11-18 |
| Date Added to Maude | 2015-01-05 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | JAMSHIDI BONE MARROW BIOPSY NEEDLE,11G, 4" |
| Product Code | FSH |
| Date Received | 2014-12-18 |
| Model Number | DJ4011X |
| Lot Number | 0000666436 |
| Device Expiration Date | 2019-03-25 |
| 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 | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-18 |