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

Model Number TJM4011

Device Problems Loose or Intermittent Connection (1371); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2017

Event Type  malfunction  

Event Description

Patient underwent a bone marrow biopsy.During the aspirate portion of the procedure it was reported that the jamshidi, the needle used to perform the biopsy, was inserted.After that the introducer was attempted to be removed.Reportedly, the blue handle fell off and the provider removed the introducer by manually pulling at the end.Reportedly, the procedure continued with the retrieval of the core biopsy of bone marrow and the marrow acquisition cradle was inserted.Upon removal of the jamshidi and cradle, it was noted that the tip of the cradle was twisted and loose.The procedure was reportedly completed without any patient harm.

• Brand Name: JAMSHIDI
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): CAREFUSION 2200, INC.; 400 east foster rd.; mannford OK 74044
• MDR Report Key: 6493193
• MDR Text Key: 72812687
• Report Number: 6493193
• 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: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: TJM4011
• Device Lot Number: 0001033070
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR