Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 500
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MILTENYI BIOTEC B.V. & CO. KG CRYOMACS FREEZING BAG 500 Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 12/17/2015
Event Type  malfunction  
Manufacturer Narrative
As this is a resubmission not all codes could be chosen, likely the codes changed in the meantime: the following were defined in the original submission.(b)(4).
 
Event Description
The customer complained about a broken cryomacs freezing bag 500 when taking the bag out of the vapour phase of the liquid nitrogen tank.There was sufficient cellular material left in another bag to facilitate the patient's therapy.The customer stated that there was no risk for the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 (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 Key5550185
MDR Text Key244391353
Report Number3005290010-2016-00060
Device Sequence Number1
Product Code KSR
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Remedial Action Notification
Type of Report Initial
Report Date 02/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date04/30/2016
Device Model NumberN/A
Device Catalogue Number200-074-402
Device Lot Number6130328005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-