MAUDE Adverse Event Report: CHARTER MEDICAL LTD. TRU-FLO NEO 40 SYRINGE SET

Catalog Number	N40-960-33
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Neo filter blood tubing cap did not twist off of the tubing.There was a delay in administering prbc's to the pt since new equipment was necessary.

• Brand Name: TRU-FLO NEO 40 SYRINGE SET
• Common Device Name: TRU-FLO NEO 40 SYRINGE SET
• Manufacturer (Section D): CHARTER MEDICAL LTD.; winston-salem NC 27103
• MDR Report Key: 7128151
• Report Number: MW5074092
• Device Sequence Number: 10098998
• Product Code: CAK
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 12/15/2017

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: 08/31/2020
• Device Catalogue Number: N40-960-33
• Device Lot Number: 146918
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Weight: 4