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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 500
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MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 500 Back to Search Results
Catalog Number 200-074-402
Medical Device Problem Codes Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/27/2021
Type of Reportable Event Malfunction
Event or Problem Description
Customer was using a cryomacs freezing bag 500 and preparing sample freeze down.During this process, the customer noticed a leak.A part of the product was rescued, some cells were lost.The customer provided a video.
 
Event or Problem Description
Customer was using a cryomacs freezing bag 500 and preparing sample freeze down.During this process, the customer noticed a leak.A part of the product was rescued, some cells were lost.The customer provided a video.
 
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Brand Name
CRYOMACS FREEZING BAG 500
Common Device Name
CRYOMACS FREEZING BAG 500
Manufacturer (Section D)
MILTENYI BIOTEC B.V. & CO. KG
friedrich-ebert-str. 68
bergisch gladbach, 51429
GM  51429
MDR Report Key12065371
Report Number3005290010-2021-00012
Device Sequence Number3821084
Product Code KSR
UDI-Device Identifier04049934000294
UDI-Public4049934000294
Combination Product (Y/N)N
Initial Reporter CountryEI
PMA/510(K) Number
BK090020
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 07/07/2021
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 Number200-074-402
Device Lot Number7200200316
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/27/2021
Supplement Date Received by Manufacturer05/27/2021
Initial Report FDA Received Date06/25/2021
Supplement Report FDA Received Date07/07/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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