MERIT CUSTOM KIT K12-MZT8231

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 2019-03-15 for MERIT CUSTOM KIT K12-MZT8231 manufactured by Merit Medical Systems Inc..

Event Text Entries

[138939049] 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


[138939050] The distributor alleged that a foreign object was found inside the fluid path of the stopcock. 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


[143030517] The suspect device was returned for evaluation. The complaint is confirmed. The root cause is attributed to the manufacturing process. A review of the device history record was performed and no exception documents were found. A review of the complaint database was performed and no similar complaints for this lot number were found.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1721504-2019-00021
MDR Report Key8425051
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-03-15
Date of Report2019-02-13
Date of Event2018-12-19
Date Mfgr Received2019-03-18
Device Manufacturer Date2018-07-25
Date Added to Maude2019-03-15
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 ContactMRS. KATIE SWENSON CQE,CBA,CQPA.
Manufacturer Street1600 MERIT PARKWAY
Manufacturer CitySOUTH JORDAN UT 84095
Manufacturer CountryUS
Manufacturer Postal84095
Manufacturer Phone8012531600
Manufacturer G1MERIT MEDICAL SYSTEMS INC.
Manufacturer Street1600 MERIT PARKWAY
Manufacturer CitySOUTH JORDAN, UT 84095
Manufacturer CountryUS
Manufacturer Postal Code84095
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMERIT CUSTOM KIT
Generic NameCUSTOM KIT
Product CodeOEQ
Date Received2019-03-15
Returned To Mfg2019-03-06
Catalog NumberK12-MZT8231
Lot NumberH1391115
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMERIT MEDICAL SYSTEMS INC.
Manufacturer Address1600 MERIT PARKWAY SOUTH JORDAN, UT 84095 US 84095


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-15

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