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 was undergoing a bone marrow biopsy during which time a bone marrow aspirate needle was inserted into the patient.Reportedly, when the introducer was removed the handle fell off.The procedure reportedly continued and was completed without harm to the patient.

• Brand Name: JAMSHIDI
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): CAREFUSION 2200, INC; 400 east foster rd.; mannford OK 74044
• MDR Report Key: 6724858
• MDR Text Key: 80439248
• Report Number: 6724858
• 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

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TIN3015
• Device Catalogue Number: TIN3015
• Device Lot Number: 100001038740
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2017
• 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: 54 YR