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

Model Number	74401
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a bag leak during thaw.The bag was removed from cassette and placed in a sterile bag then thawed in water bath.During thaw, the cellular product was leaking from a tear in the corner of the bag.This was described as not appearing to be a puncture.Neither bag nor photos were available for investigation.A filled in questionnaire was provided.The location of the breakage was marked in a drawing.Customer tested sterility and determined no growth.According to the questionnaire the following investigation and statements could be made: the event was observed during thaw.The customer did use a metal cassette for freezing and for storage.A controlled rate freezer was used.No overwrap bag was used.The filling volume was 49 ml (30 - 70 ml are recommended).The freezing bag were stored in the vapor phase of ln2.Based on this information it is assumed that the freezing bag was cracked at the edge.The issue is likely caused by physical stress, e.G.Mechanical impact in combination with a wrong user handling.Using an overwrap bag is recommended but was not used.This is a deviation from the recommended freezing procedure.This increases the risk of squeezing the freezing bag inside the metal cassette at the edge.Breakages can also be caused by the presence of air bubbles.Due to the fact that no picture was provided, no statement can be made regarding trapped air inside the closed freezing bag.Air should absolutely be avoided in the sealed freezing bags as it will quickly expand during thaw and thereby may cause a bag breakage.It is also important not to label the bags other than recommended inside the label pocket.Also this could not be excluded.It is important to follow the recommendations for the freezing procedure as the bag material is sensitive when frozen.For the freezing bag 250 batch 7210300360, no deviation concerning the manufacturing process occurred.No anomalies occurred during the process.The incident rate for this failure is below 0.01% with no other case reported.

• 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: 15102458
• Report Number: 3005290010-2022-00004
• Device Sequence Number: 4213865
• Product Code: KSR
• UDI-Device Identifier: 04049934000287
• UDI-Public: 04049934000287
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2022

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 Expiration Date: 02/17/2024
• Device Model Number: 74401
• Device Catalogue Number: 200-074-401
• Device Lot Number: 7210300360
• 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: 07/01/2022
• Initial Report FDA Received Date: 07/26/2022
• 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