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

Model Number	74401
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports 2 cryomacs freezing bag 250 (7210900527) where the frozen cellular material was lost/impacted by a crack.The bags were not investigated.A filled questionnaire and pictures were available.According to the questionnaires the following investigation and statements could be made: the events were observed on removal from tank.The customer did use metal cassettes for freezing and for storage.A controlled rate freezer was used.Overwrap bags were not used for freezing.Using the overwrap bags is recommended.The filling volumes were 40 ml/ 60 ml (30-70 ml are recommended).The freezing bags were stored in the vapor phase of ln2.According to the pictures and the questionnaires the two cryomacs freezing bags were cracked along the edge of the bag.On one picture it can be seen, that a big adhesive label was put onto the freezing bag.The issues are likely caused by physical stress, e.G.Mechanical impact in combination with a wrong user handling.Overwrap bags were not used for freezing.This is a deviation from the recommended freezing procedure.It is conceivable that the bags have been slightly pinched or moved in the metal cassettes resulting in mechanical stress.The cryomacs freezing bags are very sensitive when frozen.Another deviation is the labeling.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 affects the product safety during the freezing process.According to the pictures it cannot clearly be seen if air bubbles are trapped inside the frozen cryomacs freezing bags.Air should absolutely be avoided in the sealed freezing bags as it will expand after during thaw and may cause a bag breakage.For the freezing bag 250 batch 7210900527, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.The incident rate for this failure is below 0.01% for this lot.

• Brand Name: CRYOMACS FREEZING BAG 250,
• Common Device Name: CRYOMACS FREEZING BAG 250,
• Manufacturer (Section D): 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: 15527948
• Report Number: 3005290010-2022-00008
• Device Sequence Number: 5991053
• Product Code: KSR
• UDI-Device Identifier: 04049934000287
• UDI-Public: 04049934000287
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/29/2022

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
• Device Model Number: 74401
• Device Catalogue Number: 200-074-401
• Device Lot Number: 7210900527
• 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: 09/21/2022
• Initial Report FDA Received Date: 10/03/2022
• 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