MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 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	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a bag that ruptured upon thawing.The patient was treated with backup material.For the cryomacs freezing bag 250 batch: 7220400221, with regard to the complaint, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.The complaint rate for this failure of this lot is below (b)(4).For investigation a filled questionnaire and pictures were available.According to the questionnaire the following investigation and statements could be made: the event were observed during thaw.The customer did use metal cassettes for freezing, but not for storage.A controlled rate freezer was used.An overwrap bag was not used for freezing.The filling volume was 65 ml (30 - 70 ml are recommended).The freezing bag was stored in the vapor phase of ln2 as intended.According to the pictures the bag cracked at the edge at the upper part of the bag near one of the spike ports and the bag label pocket.According to the crack pattern it cannot be excluded, that an air bubble was trapped at the cracked part of the bag.The issue is likely caused by physical stress, e.G.Mechanical impact during handling in combination with an improper user handling during the freezing procedure.It is suspected, that an air bubble has been trapped inside the bag at the cracked part of the bag.Air should absolutely be avoided in the sealed freezing bags as it will expand after the freezing process and may cause a bag breakage.According to the questionnaire no overwrap bag was used and a metal cassette was only used for freezing, not for storage, which are deviations from the recommended freezing process.
Additional Manufacturer Narrative
Imdrf a code 3191: "opening causing substantial loss of material after thawing".

• 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 (Section G): 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: 16589124
• Report Number: 3005290010-2023-00005
• Device Sequence Number: 14875699
• Product Code: KSR
• UDI-Device Identifier: 04049934000287
• UDI-Public: 04049934000287
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 03/21/2023

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: 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: 03/13/2023
• Initial Report FDA Received Date: 03/22/2023
• 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