MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS

Model Number CF-250-3L

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2018

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, which would have occurred during 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

The user of the device discovered blood product leaking at the edge of the bag.There was no report of an adverse event or need for additional medical intervention as a result of this occurrence.

• Brand Name: 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS
• Type of Device: 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS
• Manufacturer (Section D): CHARTER MEDICAL, LTD.; 3948-a westpoint blvd.; winston salem 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: 8110122
• MDR Text Key: 129073676
• Report Number: 1066733-2018-00022
• 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: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/01/2022
• Device Model Number: CF-250-3L
• Device Catalogue Number: CF-250-3L
• Device Lot Number: 150349
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2018
• 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