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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 Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/06/2020
Type of Reportable Event Malfunction
Event or Problem Description
The customer reported the leakage of a bag after thawing.The bag was filled with the patient's transplant material, frozen on (b)(6) 2020 and stored in the cryogenic tank.During defrosting on (b)(6) 2020 the bag unsealed in the place for the label.The bag was discarded as enough backup material from other bags was available.
 
Event or Problem Description
The customer reported the leakage of a bag after thawing.The bag was filled with the patient's transplant material, frozen on (b)(6) 2020 and stored in the cryogenic tank.During defrosting on (b)(6) 2020 the bag unsealed in the place for the label.The bag was discarded as enough backup material from other bags was available.
 
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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 Key11271964
Report Number3005290010-2021-00001
Device Sequence Number19926400
Product Code KSR
UDI-Device Identifier04049934000294
UDI-Public4049934000294
Combination Product (Y/N)N
Initial Reporter CountryPL
PMA/510(K) Number
BK090020
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 02/10/2021
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 Number619091300
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/04/2021
Supplement Date Received by Manufacturer01/04/2021
Initial Report FDA Received Date02/03/2021
Supplement Report FDA Received Date02/11/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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