CRYOMACS FREEZING BAGS 250 N/A 200-074-401

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-04-18 for CRYOMACS FREEZING BAGS 250 N/A 200-074-401 manufactured by Miltenyi Biotec Gmbh.

Event Text Entries

[73117271] Not returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[73117272] The customer complained on cracked cryomacs? Freezing bag(s) 250 which were either removed from the liquid nitrogen freezer at their facility in (b)(6), us or transported to customers in the (b)(4) via plane using a cryo-containment unit (< -160 c). The vrhole freezing/thawing process as well as the amount of cracked bags for each lot described by the customer is actually rather unclear. Also the transport conditions for long-distance transport to (b)(4) customers is not comprehensively described by pct. Up to now there is also no information provided by the customer on the clinical outcome for the patients involved. The date of event is also unknown.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005290010-2017-00011
MDR Report Key6501096
Report SourceCOMPANY REPRESENTATIVE
Date Received2017-04-18
Date of Report2017-04-18
Date of Event2017-03-10
Date Mfgr Received2017-03-22
Device Manufacturer Date2015-05-07
Date Added to Maude2017-04-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS NANCY JOHANSEN
Manufacturer Street120 BEACON ST SUITE 200
Manufacturer CitySOMERVILLE MA 02143
Manufacturer CountryUS
Manufacturer Postal02143
Manufacturer Phone6172180062
Manufacturer G1MILTENYI BIOTEC GMBH
Manufacturer StreetFRIEDRICH-EBERT-STRASSE 68
Manufacturer CityBERGISCH GLADBACH, 51429
Manufacturer CountryGM
Manufacturer Postal Code51429
Single Use3
Remedial ActionNO
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCRYOMACS FREEZING BAGS 250
Generic NameCRYOMACS FREEZING BAGS 250
Product CodeLPZ
Date Received2017-04-18
Model NumberN/A
Catalog Number200-074-401
Lot Number6150213015
Device Expiration Date2018-01-13
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMILTENYI BIOTEC GMBH
Manufacturer AddressFRIEDRICH-EBERT-STRASSE 68 BERGISCH GLADBACH, 51429 GM 51429


Patients

Patient NumberTreatmentOutcomeDate
10 2017-04-18

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