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

Model Number	74401
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During a thawing procedure at a manufacturing site, a leak was found in the bottom left side of the bag (right at the seam).The broken bag was discarded and manufacturing continued.Product was cryopreserved on 4/30/2020 at mcct and thawing occurred on 5/6/2020 at a manufacturing site.The customer provided a filed in questionnaire and a picture for a more detailed 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 and for storage.A controlled rate freezer was used.The freezing bag was not stored with an overwrap bag for cell rescue.The filling volume was 49 ml (30 ml - 70 ml are recommended).The picture shows no questionnaire at the bottom of the eva tube.The root cause in this case cannot be determined, as no leakage is visible on the picture.Therefore no reference to the complaint was possible.According to the questionnaire the missing overwrap bag is a deviation from the recommended freezing procedure.Regarding to the described issue, this should not have an influence, but cannot be excluded.Typically, a crack or leakage is caused by mechanical stress during the handling of the frozen product.The incident rate for this failure for this lot is very low with 0.01%.

• 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: 10212195
• Report Number: 3005290010-2020-00016
• Device Sequence Number: 2613765
• Product Code: KSR
• UDI-Device Identifier: 04049934000287
• UDI-Public: 04049934000287
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2020

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: No Information
• Device Expiration Date: 08/05/2022
• Device Model Number: 74401
• Device Catalogue Number: 200-074-401
• Device Lot Number: 6190905042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1