MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. 75-ML CELL FREEZE CRYOGENIC STORAGE CONTAINER

Model Number CML-75LN

Device Problems Break (1069); Crack (1135); Fracture (1260); Device Issue (2379); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2017

Event Type  malfunction  

Manufacturer Narrative

The sample was not available for investigation.The root cause of the film crack could not be conclusively determined and the exact point in the process where the film crack occurred is unknown.There are other potential causes that could result in a film crack or tear: - film damage incurred during handling of a frozen bag.- a label attached to the bag surface could interfere with the flexibility of the film during cryogenic freezing and thawing processes.- overfilling the bag.An overfilled bag could create resistance during insertion and removal of the bag from the metal cassette.- excessive air left inside the bag after filling, resulting in rapid expansion during thawing.- moisture on the exterior surface of the bag or cassette interior when the bag is inserted into the metal cassette.Moisture may cause the bag film to freeze to the interior cassette surface, thus potentially resulting in damage when the frozen bag is removed from the cassette.- although there was no evidence, there is always the possibility that an undetected material issue could contribute to a tear of this nature.The product instruction for use sheet is provided with each cml-75ln device.Review of the ifu version provided with lot 142707 has the following precautions: - "do not write on bag surface, back side of label or adhere labels to bag surface." - "after freezing, do not handle excessively.Port tubes and film are fragile in the frozen state and breakage may occur.Handle with care." - "do not overfill." - "remove as much air as possible from the container." - "ensure bag exterior and protective freezing cassettes are dry prior to initiating freezing protocol.Moisture on the exterior of the bag or on the cassette could cause adherence of the bag to the cassette resulting in difficulty of bag removal.".

Event Description

The bag break was discovered during the thawing process while the cell material was being processed.There was no contact with a patient when the leak occurred.There was no injury, death or further medical intervention required as a result of this occurrence.There was no medical staff exposure as a result of this occurrence.

• Brand Name: 75-ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
• Type of Device: 75-ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
• 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: jessica hughes ; 3948-a westpoint blvd; winston salem, NC 27103 ; 3367686447
• MDR Report Key: 6631075
• MDR Text Key: 77617832
• Report Number: 1066733-2017-00006
• Device Sequence Number: 1
• Product Code: LPZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK060042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2018
• Device Model Number: CML-75LN
• Device Catalogue Number: CML-75LN
• Device Lot Number: 142707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR