SYRINGE.VACLOK FIXED MALE LUER CONNECTOR VAC160E

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-19 for SYRINGE.VACLOK FIXED MALE LUER CONNECTOR VAC160E manufactured by Merit Medical Systems Inc..

Event Text Entries

[186553316] The suspect device has been returned for evaluation. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10


[186553317] The distributor reported a foreign object inside the fluid path of a vac syringe. This was identified during their initial inspection of received product. The device was not sent to a user facility.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1721504-2020-00019
MDR Report Key9857531
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-19
Date of Report2020-02-20
Date of Event2020-02-12
Date Mfgr Received2020-02-20
Device Manufacturer Date2018-03-21
Date Added to Maude2020-03-19
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 ContactMR. DAVID LOCKRIDGE
Manufacturer Street1600 MERIT PARKWAY
Manufacturer CitySOUTH JORDAN, UT
Manufacturer CountryUS
Manufacturer Phone2084551
Manufacturer G1MERIT MEDICAL SYSTEMS INC.
Manufacturer Street1600 MERIT PARKWAY
Manufacturer CitySOUTH JORDAN,, UT
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYRINGE.VACLOK FIXED MALE LUER CONNECTOR
Generic NameVACLOCK SYRINGE
Product CodeFMF
Date Received2020-03-19
Returned To Mfg2020-03-13
Catalog NumberVAC160E
Lot NumberH1308389
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMERIT MEDICAL SYSTEMS INC.
Manufacturer Address1600 MERIT PARKWAY SOUTH JORDAN,, UT US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-19

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