MERIT HIGH PRESSURE TUBING HPT480E

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 2016-07-21 for MERIT HIGH PRESSURE TUBING HPT480E manufactured by Merit Medical Systems, Inc.

Event Text Entries

[50188923] One device was returned for evaluation. The investigation is still in progress. A follow up will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10


[50188924] A tear was found in the clear film of the packaging. This was found during the distributor's incoming inspection. The device was not sent to a user facility.
Patient Sequence No: 1, Text Type: D, B5


[51134042] One device was returned for evaluation. The device was examined visually and a hole was found in the clear film. The complaint is confirmed. The root cause is attributed to rough handling during inspection. The device history record was reviewed and no exception documents were found. The complaint database was reviewed and no similar complaints for this lot number were found.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1721504-2016-00125
MDR Report Key5813821
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2016-07-21
Date of Report2016-06-30
Date of Event2016-04-14
Date Mfgr Received2016-07-26
Device Manufacturer Date2016-01-25
Date Added to Maude2016-07-21
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. JERRY MCPHIE
Manufacturer Street1600 WEST MERIT PARKWAY
Manufacturer CitySOUTH JORDAN UT 84095
Manufacturer CountryUS
Manufacturer Postal84095
Manufacturer Phone8012084491
Manufacturer G1MERIT MEDICAL SYSTEMS, INC
Manufacturer Street1600 WEST 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 HIGH PRESSURE TUBING
Generic NameHIGH PRESSURE TUBING
Product CodeDXJ
Date Received2016-07-21
Returned To Mfg2016-07-15
Catalog NumberHPT480E
Lot NumberH898262
Device Expiration Date2018-12-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMERIT MEDICAL SYSTEMS, INC
Manufacturer Address1600 WEST MERIT PARKWAY SOUTH JORDAN UT 84095 US 84095


Patients

Patient NumberTreatmentOutcomeDate
10 2016-07-21

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