MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-22 for JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP BAK4511 manufactured by Carefusion, Inc.
[75858108]
(b)(4). A follow up emdr will be submitted upon carefusion's investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75858109]
While doing core aspiration, (it was reported) the needle broke off in the patient's iliac crest, requiring her to go to the hospital for (surgical consult) for (possible) removal of the needle. Additional information received; hospital stated they did not see the needle after mri was performed and nothing was seen. Physician reported there was no difficulty entering the iliac crest. No further intervention needed at this point. Procedure was not repeated.
Patient Sequence No: 1, Text Type: D, B5
[78167870]
(b)(4) carefusion investigation: a device history record review was completed for lot 0001062525. No issues were found, indicating that manufacturing procedures were properly followed, and subsequent quality inspections were passed. A failure could not be confirmed as no sample was available for analysis. The device history record indicated that the jamshidi bone marrow tray was built according to procedure, and quality inspections for the device were passed. Therefore, a root cause could not be identified. Based on the lack of a definitive root cause, no corrective or preventive actions were identified for the reported failure mode. This complaint will be added to the complaint trending system and will be monitored for future occurrences.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625685-2017-00295 |
| MDR Report Key | 6581296 |
| Date Received | 2017-05-22 |
| Date of Report | 2017-05-31 |
| Date of Event | 2017-04-20 |
| Date Mfgr Received | 2017-04-25 |
| Date Added to Maude | 2017-05-22 |
| 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 | 400 EAST FOSTER RD |
| Manufacturer City | MANNFORD OK 74044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 74044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP |
| Generic Name | TRAY, SURGICAL, NEEDLE |
| Product Code | FSH |
| Date Received | 2017-05-22 |
| Model Number | BAK4511 |
| Lot Number | 0001062525 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-05-22 |