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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
Device Problem Crack (1135)
Patient Problem Insufficient Information (4580)
Event Date 01/26/2022
Event Type  malfunction  
Event Description
During the thawing process the customer observed a leak of the product in form of a puddle/leak.They assume it originated from a small crack at the top of the bag.The exact spot could not be determined.The patient did not receive the cells from this bag but sufficient backup material was available.A review of the complaint database showed that no similar issue has been reported for this lot before.Incident rate below 0.01%.Investigation by subject matter expert is pending.
 
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Brand Name
CRYOMACS FREEZING BAG 500
Type of Device
CRYOMACS FREEZING BAG 500
Manufacturer (Section D)
MILTENYI BIOTEC B.V. & CO. KG
friedrich-ebert-str. 68
bergisch gladbach, 51429
GM  51429
Manufacturer Contact
bettina-judith höhlich
friedrich-ebert-str. 68
bergisch gladbach, 51429
GM   51429
MDR Report Key13584437
MDR Text Key290790126
Report Number3005290010-2022-00001
Device Sequence Number1
Product Code KSR
UDI-Device Identifier04049934000294
UDI-Public4049934000294
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
BK090020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number200-074-402
Device Lot Number720100638
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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