MAUDE Adverse Event Report: FENWAL, INC. FENWAL TRANSFER PACK CONTAINER 300ML; CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS

Model Number 4R2014

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 07/20/2021

Event Type  malfunction  

Event Description

Hpc, apheresis product was lost due a crack in the 300 ml transfer bag.After sampling, cls connected the collection bag to 300 ml transfer bag.Subsequently he noticed that the whole product was leaked out of the bag.We examined the bag and unfortunately the 300 ml transfer bag had a crack.Fenwal transfer pack container with coupler 300ml.Fda safety report id # (b)(4).

• Brand Name: FENWAL TRANSFER PACK CONTAINER 300ML
• Type of Device: CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS
• Manufacturer (Section D): FENWAL, INC.
• MDR Report Key: 12217212
• MDR Text Key: 263398585
• Report Number: MW5102731
• Device Sequence Number: 1
• Product Code: KSR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4R2014
• Device Lot Number: FA19I26146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other