MAUDE Adverse Event Report: FENWAL FENWAL DOUBLE NEEDLE WITH PLATELET ADDITIVE SOLUTION; NONE

Lot Number FA14108131

Device Problem Failure to Deliver (2338)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2014

Event Type  malfunction  

Event Description

There has been residual plasma (20 mls) remaining in the kit and not transferred to the product.Fenwal has replaced all kits with a new lot number and retrieved the lot in question.

• Brand Name: FENWAL DOUBLE NEEDLE WITH PLATELET ADDITIVE SOLUTION
• Type of Device: NONE
• Manufacturer (Section D): FENWAL; three corporate drive; lake zurich IL 60047
• MDR Report Key: 4442840
• MDR Text Key: 5391254
• Report Number: MW5040329
• Device Sequence Number: 1
• Product Code: BRZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2015
• Device Lot Number: FA14108131
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1