MAUDE Adverse Event Report: CAREFUSION, INC JAMSHIDI (TJ) NEEDLE BONE MARROW 11G X4; BIOPSY NEEDLE

Catalog Number TJC4011

Device Problems Out-Of-Box Failure (2311); Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

Initial emdr.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

Packaging was open before use: unsecured sterility.No patient harm.

Manufacturer Narrative

Pr (b)(4) follow up emdr for device evaluation.No complaint sample was provided for evaluation.Consequently, the investigation was not able to confirm the reported failure mode.A device history record review for lot 0001085188 was performed.No issues were identified that may have contributed to the reported failure mode.Since no complaint sample was provided for evaluation and the dhr review did not identify any issues that may have contributed to the reported failure mode, a probable root cause could not be identified based on the investigation results.Since no probable root cause was identified based on the complaint investigation, the investigation was not able to identify any corrective or preventive actions for this complaint.This complaint will be entered into the complaint management system and will be tracked and trended for future occurrences.

• Brand Name: JAMSHIDI (TJ) NEEDLE BONE MARROW 11G X4
• Type of Device: BIOPSY NEEDLE
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 7454096
• MDR Text Key: 107085198
• Report Number: 1625685-2018-00014
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• PMA/PMN Number: K913306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TJC4011
• Device Lot Number: 1085188
• Date Manufacturer Received: 06/11/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other