HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR 003-40

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2019-10-29 for HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR 003-40 manufactured by Teleflex Medical.

Event Text Entries

[165315788] (b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed and no relevant findings were identified. In-process qa inspections shows one noncomformance; nonconfirming material was sorted for defect, re-inspected, and found to be acceptable. Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information. Teleflex will continue to monitor and trend for reports of this nature. If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Patient Sequence No: 1, Text Type: N, H10


[165315789] Customer reported air leaked from the adaptor when connected to the flow meter. No patient involvement reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1417411-2019-00058
MDR Report Key9249590
Report SourceDISTRIBUTOR,FOREIGN,USER FACI
Date Received2019-10-29
Date of Report2019-10-10
Date of Event2019-05-16
Date Mfgr Received2019-11-20
Device Manufacturer Date2018-06-13
Date Added to Maude2019-10-29
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
Generic NameHUMIDIFIER NEBULIZER KIT
Product CodeOGG
Date Received2019-10-29
Returned To Mfg2019-10-31
Catalog Number003-40
Lot Number18B241
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressMORRISVILLE NC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.