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

Model Number CF-250

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2018

Event Type  malfunction  

Manufacturer Narrative

The returned bag was visually inspected; a tear in the film, approximately 1/8-inch in length, was observed in the junction area of two bag welds.The film edges of the tear had a stretch appearance as if the film had been pulled apart.The failure mode was unique from previous leak reports involving this product style in several ways: previous complaints have been attributed to user handling technique issues after the bags were frozen.This one occurred during the filling process.Failure modes from previous reports presented themselves as small pin holes or film cracks.The exact root cause was undetermined.However, a review of the bag production process indicated a single manual process step where an issue of this nature could possibly occur.The bag is produced with 2 separate layers of film, which are manually placed on tooling and welded.If one of the film layers is not manually placed in a flat orientation, there is a possibility the weld tooling could pinch the film near the port weld junction and result in a tear or hole.This is the location where the bag tear was observed on the returned sample.Since there have been no known previous reports of this nature this issue appears to be an isolated occurrence.

Event Description

The end user experienced a leak from a possible film tear in a cf-250 device while the bag was being filled.The cell material was not salvaged from the bag and was not infused into the patient.There were no adverse events or additional medical intervention required as a result of this occurrence.

• Brand Name: 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
• Type of Device: 30-70ML 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 27103
• Manufacturer Contact: jessica hughes ; 3948-a westpoint blvd.; winston salem 27103 ; 3367686447
• MDR Report Key: 7872603
• MDR Text Key: 120576291
• Report Number: 1066733-2018-00015
• 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: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/11/2021
• Device Model Number: CF-250
• Device Catalogue Number: CF-250
• Device Lot Number: 151223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2017
• 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