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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CRYOMACS FREEZING BAG 500
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MILTENYI BIOTEC GMBH CRYOMACS FREEZING BAG 500 Back to Search Results
Model Number N/A
Device Problems Crack (1135); Material Deformation (2976)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
The customer reported on cracked luer connector threads within three cryomacs freezing bags 500 during fluid transfer prior to freezing.Since the customer could rescue the cellular material any risk for the patient could be ruled out.The date of the event is unknown.
 
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Brand Name
CRYOMACS FREEZING BAG 500
Type of Device
FREEZING BAG
Manufacturer (Section D)
MILTENYI BIOTEC GMBH
friedrich-ebert-strasse 68
bergisch gladbach, 51429
GM  51429
Manufacturer (Section G)
MILTENYI BIOTEC GMBH
friedrich-ebert-strasse 68
bergisch gladbach, 51429
GM   51429
Manufacturer Contact
nancy johansen
85 hamilton st
cambridge, MA 02139
6172180062
MDR Report Key5612767
MDR Text Key44508144
Report Number3005290010-2016-00063
Device Sequence Number1
Product Code KSR
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
BK090020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial
Report Date 04/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/14/2018
Device Model NumberN/A
Device Catalogue Number200-074-402
Device Lot Number6150914017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2016
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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