HUDSON ADULT ISO-GARD DRAIN 830

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 2016-08-29 for HUDSON ADULT ISO-GARD DRAIN 830 manufactured by Teleflex Medical.

Event Text Entries

[53391611] (b)(4). The results of the investigation are incomplete at the time of this report.
Patient Sequence No: 1, Text Type: N, H10


[53391612] The customer alleges that the valve of the device leaks which causes water to spit out and lose volume from the ventilator. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


[58495506] Qn#(b)(4). A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint. The sample was not returned for evaluation; therefore, ten pieces of the same catalog number were selected from current production at the manufacturing facility. A visual exam was performed and no defects were observed on the samples. In addition, all ten pieces passed a leak test. In the current manufacturing procedure, 100% leak testing is conducted at the assembly area; thus, any defects would be detected prior to release. The complaint could not be confirmed as the actual sample was not returned for evaluation, and no visual or functional issues were found on the samples taken from production.
Patient Sequence No: 1, Text Type: N, H10


[58495507] The customer alleges that the valve of the device leaks which causes water to spit out and lose volume from the ventilator. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8040412-2016-00184
MDR Report Key5910877
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2016-08-29
Date of Report2016-08-23
Date of Event2016-08-22
Date Mfgr Received2016-10-13
Date Added to Maude2016-08-29
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 StreetPO BOX 28, 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 NameHUDSON ADULT ISO-GARD DRAIN
Generic NameDRAIN, TEE (WATER TRAP)
Product CodeBYH
Date Received2016-08-29
Catalog Number830
Lot Number201313
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressPERAK, WEST MALAYSIA


Patients

Patient NumberTreatmentOutcomeDate
10 2016-08-29

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