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	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a leakage of a cryomacs freezing bag 750 upon thawing.The cells were not used for transplantation but backup material was thawed and used.This is the first complaint for this lot with a complaint rate below 0.01%.The customer provided a questionnaire and pictures for the investigation.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.· 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 pictures the cryomacs freezing bag is cracked at one of the edges.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.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 a metal cassette was used for freezing but not for storage.An overwrap bag was not used.It is conceivable that the bags have been slightly pinched or moved in the metal cassettes at the edge resulting in the cracked edge.The cryomacs freezing bags are very sensitive when frozen and it is strongly recommended to frozen the cryomacs freezing bags according to the recommended freezing procedure.A crack at the edge of the cryomacs freezing bag can also occur, e.G.If air is enclosed in 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.
Additional Manufacturer Narrative
3191 opening causing substantial loss of material after thawing.

• 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 Contact: bettina-judith höhlich ; friedrich-ebert-str. 68; bergisch gladbach, 51429 ; GM 51429
• MDR Report Key: 17912014
• Report Number: 3005290010-2023-00012
• Device Sequence Number: 6626971
• 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): 11/10/2023

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: 200-074-403
• 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: 09/20/2023
• 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