MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 750

Catalog Number	200-074-403
Medical Device Problem Codes	Fracture (1260); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
3191 "opening causing substantial loss of material after thawing".
Event or Problem Description
The customer reported loss of material as the tubing broke at joint between the bag and the tubing after thawing.The customer provided a questionnaire and a picture of the affected bag.According to the questionnaire the following investigation and statements could be made: the event was observed during thawing.The customer did use a metal cassette for freezing but not for storage.A controlled rate freezer was used.An overwrap bag was not used for freezing.It was only used during thawing in the water bath.The filling volume was 150 ml (80 - 190 ml are recommended).The freezing bag was stored in the vapor phase of ln2.According to the picture the eva tube is cracked off the cryomacs freezing bag at the connection from the tube to the bag.It can be seen that an adhesive label was put onto the surface of the cryomacs freezing bag.For the cryomacs freezing bag 750 batch 7221100100, with regard to the complaint, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.Complaint rate for this lot and this failure is below (b)(4).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 questionnaire an overwrap bag was not used for freezing.It was only used during thawing in the water bath.A metal cassette was used for freezing, but was removed for storage.No statement is made about how the cryomacs freezing bag was stored instead.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.It is possible that the connection of the tube and the bag has cracked off due to mechanical stress, e.G.During removal of the metal cassette.The tube may have been slightly pinched in the metal cassette or the metal cassette in which the frozen bag was frozen was roughly moved after freezing and lead to the crack.The connection may have also been affected during storage.If the frozen bag is placed in the overwrap bag for thawing in a water bath, this is not according to the validated standard protocol.Risks could e.G.Be that air can be trapped between the cryomacs freezing bag and the overwrap bag.This should absolutely be avoided as it will expand and may cause a bag breakage.Additionally the labeling is a deviation from the recommended freezing procedure.Big adhesive labels were put onto the cryomacs freezing bag.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.In this case, it is unlikely that it is related to the fracture.

• Brand Name: CRYOMACS FREEZING BAG 750
• Common Device Name: CRYOMACS FREEZING BAG 750
• 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 hö]hlich ; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 18711207
• Report Number: 3005290010-2024-00002
• Device Sequence Number: 6945653
• Product Code: KSR
• UDI-Device Identifier: 04049934000300
• UDI-Public: 04049934000300
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/15/2024

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: 200-074-403
• Device Lot Number: 7221100100
• 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: 01/19/2024
• Initial Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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