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

Catalog Number	200-074-401
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	09/11/2023
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
The customer reported a cryomacs freezing bag 250 that broke upon tank removal.The customer provided pictures and a filled in questionnaire.According to the questionnaire the following investigation and statements could be made: the event was observed on removal from tank; the customer did not use a metal cassette for freezing or for storage; a controlled rate freezer was not used; an overwrap bag was not used for freezing; the filling volume was 67 ml (30 - 70 ml are recommended); the freezing bag was stored in the liquid phase of ln2 and placed in vapor phase prior to removal from storage tank.According to the pictures the cryomacs freezing bag cracked over the entire bag.The crack pattern indicates that it started from one spot and spread over the entire area.For the cryomacs freezing bag 250 batch 7220400221 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.There are several deviations from the recommended freezing procedure.According to the questionnaire neither a metal cassette nor an overwrap bag was used for freezing and for storage.As well a controlled rate freezer was not use.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 crack pattern indicates that it started from one spot and spread over the entire area.This possibly indicates the presence of an air bubble at this point.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.The complaint rate for this failure for this lot is low with (b)(4).

• 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: 17911115
• Report Number: 3005290010-2023-00011
• Device Sequence Number: 6636482
• Product Code: KSR
• UDI-Device Identifier: 04049934000287
• UDI-Public: 04049934000287
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/11/2023

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 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: 09/18/2023
• Initial Report FDA Received Date: 10/11/2023
• 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