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

Model Number	74401
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	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
3191 (a27) - appropriate term/code not available: "opening causing substantial loss of material after thawing".
Event or Problem Description
Customer states they utilize cryomacs bags for cell therapy product storage and infusion.Product was thawed at patient bedside, large crack noticed in the upper corner of the bag.The complaint rate for this lot is below 0.01%.For the cryomacs freezing bag 250 batch 7220800467, with regard to the complaint, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process for investigation a picture and a filled in questionnaire was available.According to the questionnaire the following investigation and statements could be made: · the events were observed during thaw.· the customer did use metal cassettes for freezing and for storage.· a controlled rate freezer was used.· an overwrap bag was used for freezing.No statement is made if the overwrap bag was welded and evacuated.· the filling volume was 51 ml (30 to 70 ml are recommended).· the cryomacs freezing bag was stored in the vapor phase of ln2.According to the picture the issue can be confirmed.The freezing bag is cracked at the edge of the bag.It can be seen that a big adhesive label was put onto the freezing bag.The issue is likely caused by physical stress, e.G.Mechanical impact in combination with an improper user handling during the freezing procedure.According to the questionnaire an overwrap bag was used, but no statement is made if the overwrap bag was welded and evacuated.If not this would be a deviation from the recommended freezing procedure as the bag should be welded and evacuated as air (ln2) could be trapped between the overwrap bag and the cryomacs freezing bag.Air should absolutely be avoided as it will expand after the freezing process and may cause a bag breakage.Additionally the labeling is a deviation from the recommended freezing procedure.A big adhesive label was put onto the 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 affects the product safety during the freezing process.

• 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 Contact: bettina-judith höhlich ; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 17097613
• Report Number: 3005290010-2023-00008
• Device Sequence Number: 1894712
• Product Code: KSR
• UDI-Device Identifier: 04049934000287
• UDI-Public: 04049934000287
• Combination Product (Y/N): N
• 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): 06/09/2023

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 Model Number: 74401
• Device Catalogue Number: 200-074-401
• Device Lot Number: 7220800467
• 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: 05/19/2023
• Initial Report FDA Received Date: 06/09/2023
• 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