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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 50
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MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 50 Back to Search Results
Model Number N/A
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/22/2019
Event Type  malfunction  
Event Description
The reporter described that the doner tube broke during thawing.When a frozen mobilized cellular sample was thawed at hospital, the staff observed that the donor tube was broken down from the end part and thus the sample could not be used any more.The patient was treated with backup material.The bag was overfilled (25ml instead of a maximum of 20ml) and no overwrap bag was used to raise safety.This is the first complaint for this lot with a incident rate below (b)(4).
 
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Brand Name
CRYOMACS FREEZING BAG 50
Type of Device
CRYOMACS FREEZING BAG 50
Manufacturer (Section D)
MILTENYI BIOTEC B.V. & CO. KG
friedrich-ebert-str. 68
bergisch gladbach, 51429
GM  51429
Manufacturer (Section G)
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 Key9653722
MDR Text Key191917324
Report Number3005290010-2020-00006
Device Sequence Number1
Product Code KSR
UDI-Device Identifier04049934000270
UDI-Public04049934000270
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
BK090020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/31/2020
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
Device Operator Health Professional
Device Expiration Date07/27/2021
Device Model NumberN/A
Device Catalogue Number200-074-400
Device Lot Number6180827011
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/08/2020
Initial Date FDA Received01/31/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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