MEDEX? DOUBLE Y-CONNECTOR MX612-HRV

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-12 for MEDEX? DOUBLE Y-CONNECTOR MX612-HRV manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[72796115] Smiths medical has received the sample device. A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.
Patient Sequence No: 1, Text Type: N, H10


[72796116] It was reported that a medex? Double y-connector was attached to a patient in the intensive care unit for a profofol infusion when it was observed that the check valve started to leak within 24 hours of use. It was noted that forceps were used to disconnect the infusion and the extension, which caused the bonding material to loosen and disintegrate. No patient injury was reported. See mfr: 3012307300-2017-00901.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2017-00834
MDR Report Key6487528
Date Received2017-04-12
Date of Report2017-09-14
Date of Event2017-03-21
Date Mfgr Received2017-08-29
Date Added to Maude2017-04-12
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 ContactLISA PERZ
Manufacturer Street6000 NATHAN LANE NORTH
Manufacturer CityMINNEAPOLIS MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone7633833074
Manufacturer G1SMITHS MEDICAL INTERNATIONAL LTD
Manufacturer StreetUNIT 4 BRADWOOD COURT ST. 1 CRISPIN WAY
Manufacturer CityROSSENDALE, BB4 4PW
Manufacturer CountryUK
Manufacturer Postal CodeBB4 4PW
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMEDEX? DOUBLE Y-CONNECTOR
Generic NameTUBING, FLUID DELIVERY
Product CodeFPK
Date Received2017-04-12
Returned To Mfg2017-04-10
Catalog NumberMX612-HRV
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2017-04-12

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