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

Model Number CF-250

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

Patient Problem Insufficient Information (4580)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

The complaint samples were 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 leaks are unknown.

Event Description

The user facility reported a leak from the top of (3) cf-250 devices near the fill tube and bag weld junction.

• Brand Name: 30-70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
• Type of Device: 30-70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER, PRODUCT CODE: LPZ
• 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: charlene grilletto ; 3948-a westpoint blvd.; winston salem, NC 27103-6770 ; 2675173220
• MDR Report Key: 10788595
• MDR Text Key: 225559652
• Report Number: 1066733-2020-00015
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Model Number: CF-250
• Device Catalogue Number: CF-250
• Device Lot Number: 158373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2019
• 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