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 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

The complaint sample was not returned to the manufacturer for investigation/review.A picture provided by the reporter of this complaint was inconclusive.The failure mode, or potential root cause for the reported leak is unknown.

Event Description

A leak was detected in the connection of the tubing to the bag during the filling process.The bag and cell product inside were discarded.

• 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: lisa hinshaw ; 3948-a westpoint blvd.; winston salem, nc ; 7686447
• MDR Report Key: 9782470
• MDR Text Key: 191398520
• Report Number: 1066733-2020-00006
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/01/2023
• Device Model Number: CF-250
• Device Catalogue Number: CF-250
• Device Lot Number: 157125
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2019
• 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