MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. 10-20 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER

Model Number CF-50

Device Problems Hole In Material (1293); Material Perforation (2205); Device Issue (2379); Material Integrity Problem (2978); Physical Property Issue (3008)

Patient Problem No Information (3190)

Event Date 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

A single, used sample was received for investigation.The bag was charged with compressed air and leak tested under water; a leak was discovered from the right top corner of the bag.The area where the observed leak originated was examined, using a magnification inspection lamp, and a hole was verified in the film.The examination also revealed a film off-set issue in the perimeter weld at the port section of the bag.The offset is indicative of a film mis-alignment issue from the manufacturing process.During the manufacturing process, the bag is placed into tooling for a welding process, which requires manual film alignment.As a result of the film misalignment observed on the returned sample the manufacturing tooling likely placed stress on the film at the hole location and produced a tear, or weak area, in the film.

Event Description

While performing a final product fill in a cf-50 bag, the user reported a spill was coming from a hole in the freezing bag.The product was discarded; however the bag was saved for investigation.

• Brand Name: 10-20 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
• Type of Device: 10-20 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
• 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: 7355969
• MDR Text Key: 103281142
• Report Number: 1066733-2018-00006
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/01/2021
• Device Model Number: CF-50
• Device Catalogue Number: CF-50
• Device Lot Number: 151497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR