HUDSON PLASTIC NIPPLE AND NUT (CLEAR) 2557

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-28 for HUDSON PLASTIC NIPPLE AND NUT (CLEAR) 2557 manufactured by Teleflex Medical.

Event Text Entries

[176641266] (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


[176641267] Customer reported the patient's oxygen saturation dropped to the 70s and 80s and the swivel connector was found broken off at the flow meter, leaking oxygen around it. The adaptor was replaced and the patient's oxygen saturation improved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004365956-2020-00031
MDR Report Key9637386
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-01-28
Date of Report2020-01-14
Date of Event2020-01-14
Date Mfgr Received2020-01-14
Date Added to Maude2020-01-28
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 StreetPARQUE INDUSTRIAL FINSA
Manufacturer CityNUEVO LAREDO 88275
Manufacturer CountryMX
Manufacturer Postal Code88275
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON PLASTIC NIPPLE AND NUT (CLEAR)
Generic NameTUBING, PRESSURE AND ACCESSORI
Product CodeBYX
Date Received2020-01-28
Catalog Number2557
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressMORRISVILLE NC


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-28

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