MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-04-24 for JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP DJ4011X manufactured by Carefusion.
[5738436]
Medical specialties - broken two incidents were reported from (b)(6) hospital. One is a broken needle, the other is a belt needle (photos are available). We have not yet received the official written report from our distributor as of april 3. A sales representative of our distributor will visit the hospital next week, confirm the incident status and receive? The complaint sample. Details of incident: under investigation incident date: under investigation? Lot number: under investigation sample? Photos? Requested by customer.? Additional information received 16apr2015 from the customer: the procedure was incomplete for the first needle, which bent, and the surgeon tried to use the second needle. On the second needle, the needle reached the bone but could not be removed and broke. The broken needle remained in the patient's body and had to be removed by the orthopedist. The patient stayed one day in the hp. The procedure was to collect tissue from the ilium. It was unknown whether the tissue was collected. Additional information received 17apr2015:? Tissue could not be collected.
Patient Sequence No: 1, Text Type: D, B5
[13149778]
(b)(4). Follow up emdr will be submitted when investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[33302907]
(b)(4). One (1) sample was received for evaluation. Failure mode was confirmed as received sample was broken. Device history record review could not be performed since no lot number were provided for evaluation. Most probable cause of failure mode reported could be related with material provided from the supplier. A scar to the supplier was issued. This failure mode will be entered into the complaint tracking system and tracked and trended for future occurrences of any similar failure modes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680904-2015-00055 |
| MDR Report Key | 4726447 |
| Report Source | 01,05,07 |
| Date Received | 2015-04-24 |
| Date of Report | 2015-06-30 |
| Date of Event | 2015-04-03 |
| Date Mfgr Received | 2015-04-03 |
| Date Added to Maude | 2015-05-27 |
| 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 | 2015-04-24 |
| Returned To Mfg | 2015-05-12 |
| Model Number | DJ4011X |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2015-04-24 |