MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. 30 - 70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER

Model Number CF-250

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/16/2020

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

Bag leak under label edge on left side of bag.

• 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: charlene grilletto ; 3948-a westpoint blvd.; winston salem, nc ; 5173220131
• MDR Report Key: 10459310
• MDR Text Key: 209245366
• Report Number: 1066733-2020-00011
• 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: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2022
• Device Model Number: CF-250
• Device Catalogue Number: CF-250
• Device Lot Number: 154506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2018
• 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