MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. 55-100 ML CELL FREEZE CYROGENIC STORAGE CONTAINER

Model Number CF-500

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

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

Event Date 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

The port area at the top of the bag was visually examined.A fracture was observed in the film under the right port tube of the bag.Closer examination revealed the fracture was approximately 5/16" long.The film fracture was longitudinal and was even with the bottom of the port tube.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.

Event Description

The user reported a cryo bag break during the waterbath thawing process.A large crack of approximately 1 cm was noted near the seal where one of the ports meets the bag.

• Brand Name: 55-100 ML CELL FREEZE CYROGENIC STORAGE CONTAINER
• Type of Device: 55-100 ML CELL FREEZE CYROGENIC 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: lisa hinshaw ; 3948-a westpoint blvd.; winston salem, nc ; 7686447422
• MDR Report Key: 9801924
• MDR Text Key: 191398228
• Report Number: 1066733-2020-00007
• 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: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Model Number: CF-500
• Device Catalogue Number: CF-500
• Device Lot Number: 159167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2019
• 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