COSEAL 934074

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-08-29 for COSEAL 934074 manufactured by Baxter Healthcare - Hayward.

Event Text Entries

[53359930] Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[53359931] It was reported that a coseal device had white particulate matter at the connection of the syringe to the joiner base. This was noted when the device's packaging was opened. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


[55453714] The device was received for evaluation. Visual inspection identified white particulate matter on the base of the transfer port for the right syringe barrel. The reported condition was verified. The cause of the condition could not be determined. A nonconformance has been opened to address this issue. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1416980-2016-14664
MDR Report Key5910463
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2016-08-29
Date of Report2016-09-22
Date of Event2016-07-21
Date Mfgr Received2016-09-12
Date Added to Maude2016-08-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1BAXTER HEALTHCARE - HAYWARD
Manufacturer Street2024 W WINTON AVE
Manufacturer CityHAYWARD CA 94545
Manufacturer CountryUS
Manufacturer Postal Code94545
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOSEAL
Generic NameSEALANT,POLYMERIZING
Product CodeNBE
Date Received2016-08-29
Returned To Mfg2016-08-30
Model NumberNA
Catalog Number934074
Lot NumberHA151109
ID NumberNA
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE - HAYWARD
Manufacturer AddressHAYWARD CA


Patients

Patient NumberTreatmentOutcomeDate
10 2016-08-29

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