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 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

The sample was not returned for investigation.There were no pictures or other information provided, which may have indicated an exact failure mode.

Event Description

The customer reported a hole under a port at the seam, which resulted in the product spilling out.The hole was noticed during the thawing process.The hole occurred in a laboratory setting and did not involve a patient.The product inside the cf-250 was exposed and was not infused into a patient.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.

Manufacturer Narrative

Updated information from returned sample investigation (6/24/19) visual examination of the returned sample indicated a longitudinal break in the film, approximately 0.6-inch long.The break was located approximately 1/4-inch below the fill port and tear cap port of the bag.Film breaks of this nature are attributed to user handling while the bag is in a frozen state.A film break of the size observed on the returned sample, if it existed prior to freezing, would result in an obvious leak during the filling process (prior to freezing) at the user's facility.

• 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
• MDR Report Key: 8569018
• MDR Text Key: 143833579
• Report Number: 1066733-2019-00002
• Device Sequence Number: 1
• Product Code: LPZ
• Combination Product (y/n): N
• PMA/PMN Number: BK100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/01/2021
• Device Model Number: CF-250
• Device Catalogue Number: CF-250
• Device Lot Number: 151603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Date Manufacturer Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR