NIPRO SET BLOOD TUBING SET

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2006-11-16 for NIPRO SET BLOOD TUBING SET manufactured by .

MAUDE Entry Details

Report Number1056186-2006-00011
MDR Report Key980694
Report Source08
Date Received2006-11-16
Date of Report2006-10-20
Date Mfgr Received2006-10-20
Device Manufacturer Date2006-04-01
Date Added to Maude2008-01-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location0
Manufacturer ContactJESSICA OSWALD
Manufacturer Street3361 ENTERPRISE WAY
Manufacturer CityMIRAMAR FL 33025
Manufacturer CountryUS
Manufacturer Postal33025
Manufacturer Phone9542410870
Manufacturer G1NIPRO THAILAND
Manufacturer Street10/2 MOO8, BANGNOMKO
Manufacturer CitySENA AYUTHAYA 13110
Manufacturer CountryTH
Manufacturer Postal Code13110
Single Use3
Remedial ActionIN
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameNIPRO SET BLOOD TUBING SET
Generic NameBLOODLINE
Product CodeFIB
Date Received2006-11-16
Returned To Mfg2006-11-03
ID NumberNA
Device Expiration Date2011-03-05
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key892353


Patients

Patient NumberTreatmentOutcomeDate
10 2006-11-16

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