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,distri report with the FDA on 2019-09-23 for HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,INT 400340 manufactured by Teleflex Medical.

Event Text Entries

[165124285] (b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. 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


[165124286] Customer reported an unstable connection between the aquapak and the oxygen source. It was reported "during oxygen therapy in neonatal intensive care unit, the issue of patients' oxygen saturation also decreased due to unsaturated oxygen supply. The nurse recognizes the problem and immediately recovers the oxygen saturation, so there is no abnormality in the patient's condition. As confirmed at the time, aquak adaptor is reported as a problem caused by incorrect tightening. " no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1417411-2019-00041
MDR Report Key9106046
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-09-23
Date of Report2019-08-29
Date of Event2019-04-22
Date Mfgr Received2019-08-29
Date Added to Maude2019-09-23
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 ContactVICTORIA SANDLIN
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
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 Received2019-09-23
Catalog Number400340
Lot NumberUNKNOWN
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-23

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