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 Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2019

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.Visual examination also revealed a film off-set issue observation 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 customer reported a pinhole in a cf-250 device.The pinhole was noticed after the bag was filled.As excess air was being removed from the bag, a bubble was observed.There was no report of an adverse event or need for additional medical intervention as a result of this occurrence.There was no report of laboratory/medical staff exposure as a result of this incident.

• 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 NC 27103
• Manufacturer Contact: todd meinecke ; 3948-a westpoint blvd.; winston salem, NC 27103 ; 3367686447
• MDR Report Key: 8824153
• MDR Text Key: 211142604
• Report Number: 1066733-2019-00004
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: CF-250
• Device Catalogue Number: CF-250
• Device Lot Number: 152678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2019
• 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