CLEARGUARD HD ANTIMICROBIAL BARRIER CAP CGHD CGHD-100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-01-30 for CLEARGUARD HD ANTIMICROBIAL BARRIER CAP CGHD CGHD-100 manufactured by Pursuti Vascular, Inc..

Event Text Entries

[134462029] Actual device involved with this report was not returned for testing. The following were reviewed as part of this investigation: patient risk, frequency analysis, labelling, and applicable manufacturing records and the lots in question were manufactured per specification without deviation. The nurse that reported the event believed that the patient had manipulated the cap. There was no patient injury reported with this event.
Patient Sequence No: 1, Text Type: N, H10


[134462030] Nurse manager contacted pursuit vascular sales team member on 02 january 2019 inquiring if there had been any reports of clearguar hd antimicrobial caps coming off. Further inquiry by pursuit vascular revealed that a single patient had reported that a clearguard hd cap had come off on two (2) separate occasions.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011277191-2019-00002
MDR Report Key8288571
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-01-30
Date of Report2019-01-29
Date of Event2018-11-22
Date Mfgr Received2019-01-02
Device Manufacturer Date2018-08-28
Date Added to Maude2019-01-30
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. JAYSON BABLER
Manufacturer Street6901 EAST FISH LAKE ROAD SUIT 166
Manufacturer CityMAPLE GROVE MN 553695456
Manufacturer CountryUS
Manufacturer Postal553695456
Manufacturer Phone7633344284
Manufacturer G1PURSUIT VASCULAR, INC.
Manufacturer Street6901 EAST FISH LAKE ROAD SUITE 166
Manufacturer CityMAPLE GROVE MN 553695456
Manufacturer CountryUS
Manufacturer Postal Code553695456
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLEARGUARD HD ANTIMICROBIAL BARRIER CAP
Generic NameCLEARGUARD HD
Product CodePEH
Date Received2019-01-30
Model NumberCGHD
Catalog NumberCGHD-100
Lot Number5260
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPURSUTI VASCULAR, INC.
Manufacturer Address6901 EAST FISH LAKE ROAD SUITE 166 MAPLE GROVE MN 553695456 US 553695456


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-30

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