MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. 80 - 190 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER

Model Number CF-750

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

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

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

The samples were not returned for investigation and there were no pictures of the bags available.The user reported the bag leaks were detected during the thawing process, after freezing.There was no report of the bags leaking during the filling process or before the bags were frozen.

Event Description

A crack was detected on (2) bags after they were thawed.Both bags had cracks in the film.

• Brand Name: 80 - 190 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
• Type of Device: 80 - 190 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
• Manufacturer (Section D): CHARTER MEDICAL, LTD.; 3948-a westpoint blvd.; winston salem NC 27103 6770
• Manufacturer (Section G): CHARTER MEDICAL, LTD.; 3948-a westpoint blvd.; winston salem NC 27103 6770
• Manufacturer Contact: lisa hinshaw ; 3948-a westpoint blvd.; winston salem, NC 27103-6770 ; 3367144221
• MDR Report Key: 9603645
• MDR Text Key: 191398957
• Report Number: 1066733-2020-00004
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/01/2022
• Device Model Number: CF-750
• Device Catalogue Number: CF-750
• Device Lot Number: 152297
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2018
• 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