MAUDE Adverse Event Report: COVIDIEN MONOJET BONE MARROW BIOPSY/ASPIRATION NEEDLE J TYPE

Lot Number 143530348X

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2015

Event Type  Injury  

Event Description

During a bone biopsy procedure, the device handle broke off.The exposed portion of the needle was removed with pliers.No adverse patient outcome occurred related to this incident.Diagnosis or reason for use: anal cancer.

• Brand Name: MONOJET BONE MARROW BIOPSY/ASPIRATION NEEDLE J TYPE
• Type of Device: ASPIRATION NEEDLE
• Manufacturer (Section D): COVIDIEN; mansfield MA
• MDR Report Key: 5311418
• MDR Text Key: 33958730
• Report Number: MW5058598
• Device Sequence Number: 1
• Product Code: GDM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Lot Number: 143530348X
• Other Device ID Number: K577292913010111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR