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

Model Number	74401
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer complains two cracked freezing bag 250 (7200108305).The bag was not available for investigation.The customer sent pictures for a more detailed investigation with the marked location of the breakage.Due to the quality of the pictures, the issue cannot be seen.A filled in questionnaire was available.The following investigation and statements could be made: the event was observed during thawing.The customer did not use a metal cassette for freezing but for storage.A controlled rate freezer was used.The freezing bag was not stored with an overwrap bag as recommended for cell rescue.The filling volume was 40 ml (30 - 70 ml are recommended).According to the questionnaire, the missing metal cassette for freezing is a deviation from the recommended freezing procedure.If the bag has been placed in the metal cassette for storage after freezing, it is not guaranteed that the liquid is evenly distributed in the bag and it may have occurred pressure marks at the bag.It cannot be excluded that this contributed to the breakage.The missing overwrap bag is also a deviation from the recommended freezing procedure, but regarding to the described issue, this should not have an influence, but cannot be excluded.The issue likely occurred due to physical stress (e.G.Mechanical impact) during handling.This is the first complaint for this lot 7200108305 with an incident rate (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
• MDR Report Key: 10406926
• Report Number: 3005290010-2020-00018
• Device Sequence Number: 3177343
• Product Code: KSR
• UDI-Device Identifier: 04049934000287
• UDI-Public: 04049934000287
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: BK090020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2020

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: 12/22/2022
• Device Model Number: 74401
• Device Catalogue Number: 200-074-401
• Device Lot Number: 7200108305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1