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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CRYOMACS FREEZING BAG 250
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MILTENYI BIOTEC GMBH CRYOMACS FREEZING BAG 250 Back to Search Results
Model Number 200-074-401
Device Problems Material Puncture/Hole (1504); Material Perforation (2205)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 05/17/2016
Event Type  malfunction  
Event Description
The customer received a set of five cryomacs freezing bags 250 containing apheresis products.One of the five products showed a leak after the lower butterfly tab was removed.The leak appeared before spiking occurred.The bags are used for r&d purposes.No risk for any patient.
 
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Brand Name
CRYOMACS FREEZING BAG 250
Type of Device
CRYOMACS FREEZING BAG 250
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 Key5762456
MDR Text Key48573568
Report Number3005290010-2016-00074
Device Sequence Number1
Product Code LPZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial
Report Date 06/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/07/2017
Device Model Number200-074-401
Device Catalogue Number200-074-401
Device Lot Number6150107002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2015
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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