MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS

Model Number CF-250-3L

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2018

Event Type  malfunction  

Manufacturer Narrative

A single, used bag was received and visually inspected by engineering staff.Inspection revealed a film tear under the right spike port.The tear was jagged and non-linear, approximately 3/4-inch long, and extended from below the tear cap port to the perimeter weld location.A small portion of the tear extended approximately 1/8-inch into the perimeter weld.A capa had previously been issued to investigate film breaks of this nature.A review of the capa investigation indicated failure modes of this type have been reproduced by introducing an air bubble inside the bag prior to freezing.An air bubble could rapidly expand during the thawing process, resulting in a film tear.The evidence observed from the returned sample indicates the likely root cause of the cracked film was the existence of an air bubble in the bag prior to freezing.Precautions for air bubbles inside the bag prior to freezing are addressed in the product ifu's.

Event Description

The bag was used to store and transport a manufactured product.The end user experienced a leak from a possible film tear in a cf-250-3l device while the bag was being thawed after frozen for 3-months.The bag contained a finished manufactured product used for a patient study point.The contents of the bag were not infused into a patient.There were no adverse events or additional medical intervention required as a result of this occurrence.

• Brand Name: 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS
• Type of Device: 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS
• Manufacturer (Section D): CHARTER MEDICAL, LTD.; 3948-a westpoint blvd.; winston salem NC 27103
• Manufacturer (Section G): CHARTER MEDICAL, LTD.; 3948-a westpoint blvd.; winston salem NC 27103
• Manufacturer Contact: jessica hughes ; 3948-a westpoint blvd.; winston salem, NC 27103 ; 3367686447
• MDR Report Key: 7876191
• MDR Text Key: 120576334
• Report Number: 1066733-2018-00014
• Device Sequence Number: 1
• Product Code: LPZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/07/2021
• Device Model Number: CF-250-3L
• Device Catalogue Number: CF-250-3L
• Device Lot Number: 149037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR