HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,INT 400340

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-08-02 for HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,INT 400340 manufactured by Teleflex Medical.

Event Text Entries

[153238201] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[153238202] Customer complaint states: "presence of a bubble in the plastic part that connects the plug in of the oxygen to the aquapack bottle. So it occludes the flow of oxygen. " the condition of the patient is reported as "fine".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1417411-2019-00035
MDR Report Key8856970
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-08-02
Date of Report2019-07-08
Date of Event2018-11-12
Date Mfgr Received2019-10-09
Device Manufacturer Date2017-05-05
Date Added to Maude2019-08-02
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 ContactKATHARINE TARPLEY
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334854
Manufacturer G1TELEFLEX MEDICAL
Manufacturer Street900 WEST UNIVERSITY DR.
Manufacturer CityARLINGTON HEIGHTS IL 60004
Manufacturer CountryUS
Manufacturer Postal Code60004
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,INT
Generic NameHUMIDIFIER NEBULIZER KIT
Product CodeOGG
Date Received2019-08-02
Returned To Mfg2019-07-08
Catalog Number400340
Lot Number220177
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-02

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