MAUDE Adverse Event Report: CAREFUSION CAREFUSION JAMSHIDI BONE MARROW BIOPSY/ASPIRATION NEEDLE, 116X4; INSTRUMENT BIOPSY

Model Number	BEK3411
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Defective jamshidi bone marrow biopsy/aspiration needle would not draw as vacuum could not be established.This caused the patient significant pain in several unsuccessful attempts to aspirate.New kit opened and jamshidi worked normally.A tiny leak was demonstrated at the hub of the defective jamshidi.Fda safety report id # (b)(4).

• Brand Name: CAREFUSION JAMSHIDI BONE MARROW BIOPSY/ASPIRATION NEEDLE, 116X4
• Common Device Name: INSTRUMENT BIOPSY
• Manufacturer (Section D): CAREFUSION; vernon hills IL 60061
• MDR Report Key: 9467050
• Report Number: MW5091651
• Device Sequence Number: 399259
• Product Code: KNW
• UDI-Device Identifier: 10885403057250
• UDI-Public: 10885403057250
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: BEK3411
• Device Catalogue Number: BEK3411
• Device Lot Number: 0001279423
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 26