MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-08-28 for JAMSHIDI NEEDLE BONE MARROW 13GX3.5 ASP DJ3513X manufactured by Carefusion.
[4802774]
Via email it was reported that the needle broke apart from the component that pulls it in and out. It was stuck in the patient and the nurse had to use other resources to grab the needle and pull it out of the patient.? Another one from same lot number was used when this one didn? T work, and that other one worked fine.? There was no injury involved. On (b)(6) 2014, the customer ((b)(6)) provided the following information as received from the end user: the bone being biopsied was the posterior iliac crest. There was nothing noted of the needle prior to patient use that would indicate a defect. The physician did not experience any difficulty when inserting the needle into the patient. The issue occurred during the first biopsy attempt. The impact to the patient was the need for repeat attempt at biopsy? So may have had increased pain at site but likely minimal if any. The patient's current status is:? No issues related to biopsy.
Patient Sequence No: 1, Text Type: D, B5
[11994598]
(b)(4). Investigation results: one sample was received for evaluation. During visual inspection, it was noted that the cannula needle was completely detached. Therefore, the reported condition was confirmed. A review of applicable manufacturing, inspection, and packaging procedures did not identify any issues that may have contributed to the reported condition. Procedures require verification of the condition of the assembled needle and functionality prior to releasing the product. In addition, no issues were found during review of the internal production records for the lot indicated that could result in the reported condition. This includes review of all raw material and components used during the manufacture of the lot involved. Based on the investigation results, it was determined that the most probable root cause could be related to material provided from the supplier. As a result, a formal supplier corrective action request has been issued to the supplier to address the reported issue. In addition, the manufacturing plant will continue to monitor this issue to identify the need for any further actions.
Patient Sequence No: 1, Text Type: N, H10
[33301831]
(b)(4). One sample was received. During sample visual inspection it was noticed that the cannula needle was completely detached and the failure mode was confirmed. There were no issues found during the applicable manufacturing process that can relate personnel with the reported failure mode. It is considered material could be related to failure mode reported. However, component that presents the failure is from a supplier and is not altered by the carefusion (b)(4) manufacturing facility prior to final assembly. The supplier has been contacted regarding this issue
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680904-2014-00035 |
| MDR Report Key | 4044338 |
| Report Source | 06 |
| Date Received | 2014-08-28 |
| Date of Report | 2014-07-29 |
| Date of Event | 2014-07-15 |
| Date Mfgr Received | 2014-07-29 |
| Date Added to Maude | 2014-09-11 |
| 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 13GX3.5 ASP |
| Generic Name | TRAY, SURGICAL, NEEDLE |
| Product Code | FSH |
| Date Received | 2014-08-28 |
| Returned To Mfg | 2014-08-07 |
| Model Number | DJ3513X |
| Lot Number | 0000489359 |
| 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 | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-28 |