MAUDE Adverse Event Report: CHARTER MEDICAL CHARTER MEDICAL CRYOBAG; CRYOBAG STORAGE CONTAINER

Lot Number 142707

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

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

Event Date 04/20/2017

Event Type  malfunction  

Event Description

It was reported that during thaw of a patient product, the bag integrity was compromised, accounting for an approximate 10ml loss of an 80ml product.The bag was removed to the bmt cell therapy lab for recovery.Investigation of the break showed the seam between the port and the bag broke.

• Brand Name: CHARTER MEDICAL CRYOBAG
• Type of Device: CRYOBAG STORAGE CONTAINER
• Manufacturer (Section D): CHARTER MEDICAL
• MDR Report Key: 6521803
• MDR Text Key: 73825778
• Report Number: MW5069315
• Device Sequence Number: 1
• Product Code: LPZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 142707
• Was Device Available for Evaluation?: Yes
• 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