MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-11-09 for JAMSHIDI NEEDLE BONE MARROW 8GX4 ASP DJ4008X manufactured by Carefusion.
[3028073]
The needle? Has broken? During the procedure.? A medical intervention has been reported to extract the remaining? Bit of the needle? From the bone. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10299309]
(b)(4). As a sample was not received for evaluation, the reported condition could not be confirmed and the most probable root cause could not be determined. A review of applicable manufacturing procedures and quality plan inspections did not identify any issues that may have contributed to the reported condition. Manufacturing and packaging processes are in place that requires personnel to perform a visual inspection and verification of a needle prior to the needle passing to the next stage. An inspection process in place also requires for the functional condition of a needle to be verified as well as a visual examination of the needle assembly prior to release of the product. During review of the applicable manufacturing, inspection, and packaging processes, no issues were found that could relate personnel or processes to the reported condition. In addition, it is not considered that the condition of the material could be related to the reported condition. There is no evidence that instructions for use (ifu) were not followed properly; however, the description provided by the customer did not mention the angle to which the steady pressure and twisting motion were applied. Specific sections of the ifu are outlined for proper use of the product. In order to prevent recurrence, the applicable procedure at the manufacturing plant level will be revised to specifically include inspection for a broken or damaged needle. The manufacturing plant personnel will also be made aware of this report to heighten awareness.
Patient Sequence No: 1, Text Type: N, H10
[17406286]
(b)(4). The sample involved was received for evaluation. Evaluation summary: one sample was received for evaluation. During sample evaluation, it was noted that the cannula was broken; therefore, the reported condition was confirmed. The investigation determined that the material used for manufacture of the product was unrelated to the reported condition as raw materials used to manufacture the cannula needle passed all the applicable quality requirements. The most probable root cause could not be determined, as during review of the applicable manufacturing, inspection, and packaging processes, no issues were found that could relate personnel, processes or materials to the reported condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680904-2012-00046 |
| MDR Report Key | 2826937 |
| Report Source | 01,06 |
| Date Received | 2012-11-09 |
| Date of Report | 2012-10-12 |
| Date of Event | 2012-10-11 |
| Date Mfgr Received | 2012-12-14 |
| Date Added to Maude | 2013-02-19 |
| 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 | 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 8GX4 ASP |
| Generic Name | TRAY, SURGICAL, NEEDLE |
| Product Code | FSH |
| Date Received | 2012-11-09 |
| Returned To Mfg | 2012-11-15 |
| Model Number | DJ4008X |
| Lot Number | 0000371270 |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2012-11-09 |