MAUDE Adverse Event Report: CAREFUSION 2200, INC JAMSHIDI; BIOPSY NEEDLE

Model Number TIN3015

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2017

Event Type  malfunction  

Event Description

Patient undergoing bone marrow biopsy.Reportedly, after the bone marrow aspirate needle was inserted into the patient, the introducer was removed and the handle fell off.The procedure continued without reported incident and no patient harm was reported.

• Brand Name: JAMSHIDI
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): CAREFUSION 2200, INC; 400 east foster rd.; mannford OK 74044
• MDR Report Key: 6724853
• MDR Text Key: 80439523
• Report Number: 6724853
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TIN3015
• Device Catalogue Number: TIN3015
• Device Lot Number: (10)0001038740
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR