MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-09-28 for JAMSHIDI BONE MARROW TRAY 11G X4 15G ASP BAK4511 manufactured by Carefusion, Inc.
[55823924]
(b)(4) initial emdr submission. A follow up emdr will be submitted upon completion of investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[55823925]
Sales rep stated via email: the user was trying to get a sample out of the jamshidi needle and stuck her thumb with the needle (on 2 different dates). Additional information received 19sept2016: approx 2 wks later. Same scenario. (see (b)(4): dr. (b)(6) performed bone marrow procedure. Was having difficulty removing sample fm coring needle. Was really jammed in. Was pushing for approx. 10 mins and could not get it to budge. Passed it off to his ma who continued to work with it and in the process she somehow nicked/scraped herself w/bone marrow needle. Was successful in getting core sample out. Same lot of bone marrow kits. Same physician, same ma. Only difference, this time ma was aware of stick. Of note both times protocol was followed. Ma went to hr for health screening follow up. Ma was interviewed regarding bone marrow policy and procedure w/emphasis on safety.
Patient Sequence No: 1, Text Type: D, B5
[60683101]
(b)(4) follow up emdr for device evaluation. With no sample or picture to evaluate, the investigation was unable to confirm this failure mode. The dhr was reviewed and no anomalies were found during the date of production; therefore this complaint could not be confirmed. The most probable root cause of the reported complaint is product misuse, the dhr did not show any manufacturing related defects and the trend report did not reveal any adverse trends. The dhr was reviewed and no anomalies were found during the date of production; therefore this complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625685-2016-00254 |
| MDR Report Key | 5983294 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-09-28 |
| Date of Report | 2016-11-22 |
| Date of Event | 2016-08-17 |
| Date Mfgr Received | 2016-09-14 |
| Date Added to Maude | 2016-09-28 |
| 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 Phone | 8473628063 |
| 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 | 2016-09-28 |
| Model Number | BAK4511 |
| Lot Number | 0000922436 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Other | 2016-09-28 |