GOLD LATEX FOLEY, CYLINDRICAL,PAEDIATRIC 180003-000080

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-19 for GOLD LATEX FOLEY, CYLINDRICAL,PAEDIATRIC 180003-000080 manufactured by Teleflex Medical Sdn. Bhd..

Event Text Entries

[186332928] (b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10


[186332929] Customer reported that patients condition were both diagnosed with acute renal failure (due to hypovolemic shock and the other one septic shock). The medical staff would want to monitor the urine output strictly which led to the decision to insert the catheter. Before catheter insertion, urine was passing with very minimal unquantified amount. Then upon inserting the catheter, there was no urine passage to the bag, or any leakage noted. Catheter remained inserted for 4-6 hours in the patient without any output. As soon the catheter was removed, both patients immediately passed urine. We decided to not insert the catheter anymore on both case and used alternative methods (diaper weighing and placement of clean gloves for the male patient). Both incidents had the same issue not able to pass urine since the catheter was inserted then upon trying to remove it the port failed to deflate the balloon. Precipitation in the tube and obstruction, which prevents passing the fluids through it. The extraction/removal of fluid in the balloon fails in the port.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8040412-2020-00096
MDR Report Key9855885
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-19
Date of Report2020-03-09
Date of Event2019-08-22
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-19
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 ContactEFFIE JEFFERSON
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194332672
Manufacturer G1TELEFLEX MEDICAL SDN. BHD.
Manufacturer StreetLOT NO : PT2577 JALEN PERUSAHAAN 4 KAMUNTING INDUSTRIAL ESTATE
Manufacturer CityPERAK, WEST MALAYSIA 34600
Manufacturer CountryMY
Manufacturer Postal Code34600
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGOLD LATEX FOLEY, CYLINDRICAL,PAEDIATRIC
Product CodeEZL
Date Received2020-03-19
Catalog Number180003-000080
Lot Number15B04
Device Expiration Date2020-01-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL SDN. BHD.
Manufacturer AddressPERAK, WEST MALAYSIA


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-19

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