MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAGS 250

Catalog Number	200-074-401
Medical Device Problem Codes	Break (1069); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device problem code 3191 "opening causing substantial loss of material after thawing".
Event or Problem Description
The customer reported 5 cracked cryomacs freezing bags upon removal from the tank.A questionaire and pictures were provided.According to the questionnaire the following investigation and statements could be made: · the event was observed on removal from tank and during thawing.· the customer did use a metal cassette for freezing and not for storage.· a controlled rate freezer was used.· an overwrap bag was not used.· no statement is made with regard to the filling volume (10 - 20 ml are recommended).· the freezing bag was stored in the vapor phase of ln2.According to the pictures the issue can be confirmed.The cryomacs freezing bags are cracked at several locations.One bag is completely cracked.This can indicate that air was enclosed in the frozen material.The second picture shows a small crack at the edge of the bag.The third and the forth pictures show a crack over the entire length of the bag, beginning at the top of the bag near the spike ports.The fifth picture shows a crack leading from the location of the adhesive label to the edge of the bag.It can be seen that big adhesive labels were put onto the bags.For the cryomacs freezing bag 250 batch 7220400221, with regard to the complaint, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.The issue is likely caused by physical stress, e.G.Mechanical impact in combination with an improper user handling during the freezing procedure.Deviations from the recommended freezing procedure likely caused the breakage.According to the first picture it is likely that air was trapped inside the frozen material.Air should absolutely be avoided in the welded cryomacs freezing bag as it will expand after the freezing process and may cause a bag breakage.According to the questionnaire no overwrap bag was used.Edges may has been slightly pinched in the metal cassette or the metal cassette in which the frozen bag was stored was roughly moved after freezing and lead to the cracks.Additionally the labeling is a deviation from the recommended freezing procedure.Big adhesive labels were put onto the cryomacs freezing bags.It is recommended to place an identification tag into the label pocket of the freezing bag.It cannot be excluded, that a big label put onto the freezing bag during freezing affect the product safety during the freezing process.The cryomacs freezing bags are very sensitive when frozen and it is strongly recommended to freeze the cryomacs freezing bags according to the recommended freezing procedure.The rate for this incident for this lot is low with 0.04%.

• Brand Name: CRYOMACS FREEZING BAGS 250
• Common Device Name: CRYOMACS FREEZING BAGS 250
• Manufacturer (Section D): MILTENYI BIOTEC B.V. & CO. KG; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• Manufacturer (Section G): MILTENYI BIOTEC B.V. & CO. KG; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• Manufacturer Contact: bettina-judith höhlich ; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 18587149
• Report Number: 3005290010-2024-00001
• Device Sequence Number: 7140120
• Product Code: KSR
• UDI-Device Identifier: 04049934000287
• UDI-Public: 04049934000287
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK090020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 200-074-401
• Device Lot Number: 7220400221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown