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 09/12/2018

Event Type  malfunction  

Manufacturer Narrative

The cf-250 device has two spike port components.The spike port component contains a septum membrane in the interior tube.The cf-250 is 100% leak tested during production.The returned bag was visually inspected; both spike port components of the bag contained spike components.The returned bag had an area of interest identified on one of the spike port components of the bag.Two observations were noted: a tear/hole was verified on one of the spike ports.The hole occurred in the side of the spike port tube, below the septum.A hole at this location would have been detected upon filling if it existed at that time (i.E.Before a spike would have been inserted into the spike port).The hole was reported after the bag had been frozen and thawed.Additionally, a hole in this location would likely be detected during production leak test if it existed at that time.The remnants of the spike port septum membrane were observed inside the bag.This observation is likely an indication of excessive force or incorrect user technique during the spiking process.The location and nature of the hole in the spike port component, along with the process step (after thawing and hanging the bag) when the leak was detected, suggests user excessive force or spiking technique likely contributed to the hole on the returned sample.

Event Description

A leak, from the port component of a single cf-250 product was reported by the user facility.The bag was thawed for infusion and hung.A hole was observed in the port component.

• 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: 8040144
• MDR Text Key: 127866517
• Report Number: 1066733-2018-00018
• Device Sequence Number: 1
• Product Code: LPZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK1000049
• 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,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/01/2020
• Device Model Number: CF-250
• Device Catalogue Number: CF-250
• Device Lot Number: 145979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2016
• 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