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 Patient Involvement (2645)

Event Date 10/17/2018

Event Type  malfunction  

Manufacturer Narrative

The sample was not returned for investigation, however the user provided pictures of a bag from lot 149037.The pictures indicated a bag with irregular film cracks over the top portion of the bag and into the port area.No other issues were observed from the bag pictures.A capa had previously been issued to investigate film breaks of this nature.A review of the capa investigation indicated failure modes of this type have been reproduced by introducing an air bubble inside the bag prior to freezing.An air bubble could rapidly expand during the thawing process, resulting in a film tear.The evidence observed from the provided pictures suggests the likely root cause of the cracked film was the existence of an air bubble in the bag prior to freezing.Precautions for air bubbles inside the bag prior to freezing are addressed in the product ifu's.

Event Description

The information provided by the customer indicated a bag cracked during the thawing process.The crack occurred in a laboratory setting and did not involve a patient.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 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: 8077389
• MDR Text Key: 127866609
• Report Number: 1066733-2018-00021
• 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: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/01/2021
• Device Model Number: CF-250-3L
• Device Catalogue Number: CF-250-3L
• Device Lot Number: 149037
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2017
• 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