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

Model Number CF-50

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

Patient Problem No Information (3190)

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint sample, or pictures of the complaint device, was not returned to the manufacturer for investigation/review.The failure mode, or potential root cause for the reported incomplete seal is unknown.

Event Description

Cf-50 bag leaked during production - the cause was defective material from vendor.

• 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: todd meinecke ; 3948-a westpoint blvd.; winston salem, NC 27103 ; 3367686447
• MDR Report Key: 8054676
• MDR Text Key: 127866529
• Report Number: 1066733-2018-00019
• Device Sequence Number: 1
• Product Code: LPZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK1000049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/01/2022
• Device Model Number: CF-50
• Device Catalogue Number: CF-50
• Device Lot Number: 152298
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2018
• 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