MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. 80 - 190 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER

Model Number CF-750

Device Problems Hole In Material (1293); Material Perforation (2205); Device Issue (2379); Material Integrity Problem (2978); Physical Property Issue (3008)

Patient Problem No Patient Involvement (2645)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

A single, used bag was received for investigation.The bag was visually examined and no issues were observed.The bag was leak tested and a film pinhole was verified near the perimeter seal at the top portion of the bag.Visual examination of the bag under a magnification inspection lamp verified a small hole in the bag film.No other issues were observed on the bag.There is no information to suggest the hole existed at the time the bag was produced at the manufacturing facility.Other than the hole itself, there was no evidence of excessive force or damage to the bag, or associated ports and tubing.It is unknown if a manufacturing issue, or user facility issue, may have contributed to the pinhole, however there was no direct evidence of a root cause.

Event Description

The cf-750 was removed from its packaging pouch and filled with 100ml of a cell product.As the bag was being packed into a cassette, a leak was detected.There was no patient contact or infusion of cell product from the bag associated with this occurrence.

• Brand Name: 80 - 190 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER
• Type of Device: 80 - 190 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: 7637288
• MDR Text Key: 112455798
• Report Number: 1066733-2018-00013
• 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: Other
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/01/2022
• Device Model Number: CF-750
• Device Catalogue Number: CF-750
• Device Lot Number: 151751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2018
• 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