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

Model Number CF-250

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

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

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

A single, used cf-250 device was received for investigation.Visual examination of the returned sample revealed (2) fractures in the film, below one of the two tear cap ports, on both sides of the bag.One fracture was approximately 3/4-inch long and the other fracture was approximately 3/8-inch long.No other issues were observed on the bag.Since the leak was reported during the thawing process, the presumption is made that the fracture did not exist prior to freezing.A fracture of the size observed on the returned complaint sample would have resulted in an obvious leak during the filling process at the user's facility prior to freezing.User handling of the device while the bag is in a frozen state could result in a failure mode of this type.There are several possible conditions which could contribute to handling damage: - residual moisture on the outside of the bag when it was placed inside a cassette.Residual moisture could cause the bag to freeze/adhere to a cassette during the freezing process.A condition of this type could cause film damage upon removal of a frozen bag from the cassette.- handling of the bag in the frozen state.The film of a frozen bag is fragile - inadvertent manipulation or impact on the bag could cause the film to fracture.The precautions indicated above are addressed in the product ifu's.A capa has been issued to investigate reports of this nature.

Event Description

The end user reported a leak in the bag near the port components.The leak was reported during the thawing process after the bag was cryogenically frozen.

• Brand Name: 30 - 70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
• Type of Device: 30 - 70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
• Manufacturer (Section D): CHARTER MEDICAL, LTD.; 3948-a westpoint blvd.; winston salem, nc
• Manufacturer (Section G): CHARTER MEDICAL, LTD.; 3948-a westpoint blvd.; winston salem, nc
• Manufacturer Contact: charlene grilletto ; 3948-a westpoint blvd.; winston salem, nc ; 5173220131
• MDR Report Key: 10454053
• MDR Text Key: 209245065
• Report Number: 1066733-2020-00010
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Model Number: CF-250
• Device Catalogue Number: CF-250
• Device Lot Number: 701511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2020
• 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