MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-06-15 for JAMSHIDI NEEDLE BONE MARROW 11GX4 ASP DJ4011X manufactured by Carefusion, Inc.
[77656727]
(b)(4). A follow up submission will be completed upon carefusion's investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[77656728]
The needle broke off in the patient and patient had to go to theatre to have needle removed. Provider was using jamshidi and placed the needle in patient's iliac crest but was having trouble getting it out; he had to use force to remove and the handle snapped off. He then used forceps to remove the rest of the needle but it snapped again. Patients current health status is fine and no further intervention needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680904-2017-00110 |
| MDR Report Key | 6644301 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-06-15 |
| Date of Report | 2017-07-31 |
| Date of Event | 2017-06-02 |
| Date Mfgr Received | 2017-06-02 |
| Date Added to Maude | 2017-06-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | ZONA FRANCA LAS AMERICAS |
| 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 | 2017-06-15 |
| Returned To Mfg | 2017-06-20 |
| Model Number | DJ4011X |
| Lot Number | UNKNOWN |
| 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, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-15 |