MAUDE Adverse Event Report: CHARTER MEDICAL, LTD. 30-70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS

Model Number CF-250-3L

Device Problems Break (1069); Fracture (1260); Device Issue (2379)

Patient Problem No Patient Involvement (2645)

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint sample, or pictures of the complaint device, was not returned to the manufacturer for investigation/review.The failure mode, or potential root cause for the reported incomplete seal is unknown.

Event Description

The end user of the product reported an incomplete seal on the top right part of the bag, at the right side of the spike port.The issue was detected during product processing in a laboratory setting; there was no patient involvement.

• Brand Name: 30-70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS
• Type of Device: 30-70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS
• 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: 7542126
• MDR Text Key: 109625673
• Report Number: 1066733-2018-00011
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/01/2021
• Device Model Number: CF-250-3L
• Device Catalogue Number: CF-250-3L
• Device Lot Number: 149035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2017
• 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