MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAGS 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	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a bag where overwrap bag and cryomacs bag were broken during thawing.According to the questionnaire the following investigation and statements could be made: the event was observed during thawing.The customer did use metal cassettes for freezing and for storage.A controlled rate freezer was used.An overwrap bag was used.The filling volume was 100 ml (80 to 190 ml are recommended).The cryomacs freezing bag was stored in the vapor phase of ln2.Pictures of the cracked cryomacs freezing bag were provided.The issue of the cracks can be confirmed.The bag was cracked at the upper part of the bag near one of the spike ports.The issue is likely caused by physical stress, e.G.Mechanical impact in combination with an improper user handling during the freezing procedure.The bag may have been slightly pinched in the metal cassette or the metal cassette in which the frozen bag was stored was roughly moved after freezing and lead to the crack.Air bubbles may have been trapped inside the cryomacs freezing bag or between the overwrap bag and the cryomacs freezing bag.Trapped air should absolutely be avoided as it will expand after the freezing process and may cause a bag breakage.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.For the cryomacs freezing bag 750 batch 7240100088, with regard to the complaint, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.This is the first complaint for this lot.
Additional Manufacturer Narrative
Imdrf a code: 3191 "opening causing substantial loss of material after thawing".

• Brand Name: CRYOMACS FREEZING BAGS 750
• Common Device Name: CRYOMACS FREEZING BAGS 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: 20279560
• Report Number: 3005290010-2024-00007
• Device Sequence Number: 7980107
• Product Code: KSR
• UDI-Device Identifier: 04049934000300
• UDI-Public: 04049934000300
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 09/23/2024

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: 7240100088,
• 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: 09/11/2024
• Initial Report FDA Received Date: 09/23/2024
• 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