HUDSON ADL ISOGARD DUAL HTD DUAL DRAIN CIRCUI 880-36

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-03-27 for HUDSON ADL ISOGARD DUAL HTD DUAL DRAIN CIRCUI 880-36 manufactured by Teleflex Medical.

Event Text Entries

[5618194] The customer alleges that the tubing was cracked at the collection cup. The alleged issue was detected during set-up. Another device was used. No report of patient injury or harm.
Patient Sequence No: 1, Text Type: D, B5


[13165786] The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004365956-2015-00106
MDR Report Key4651087
Report Source06
Date Received2015-03-27
Date of Report2015-03-09
Date of Event2015-03-09
Date Mfgr Received2015-03-09
Date Added to Maude2015-05-13
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 FDA0
Event Location0
Manufacturer ContactMARGIE BURTON, RN REG. AFFAIRS
Manufacturer Street3015 CARRINGTON MILL BLVD.
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334965
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetPARQUE INDUSTRIAL FINSA
Manufacturer CityNUEVO LAREDO, TAMAULIPAS 88275
Manufacturer CountryMX
Manufacturer Postal Code88275
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON ADL ISOGARD DUAL HTD DUAL DRAIN CIRCUI
Product CodeCAG
Date Received2015-03-27
Returned To Mfg2015-03-18
Catalog Number880-36
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC US


Patients

Patient NumberTreatmentOutcomeDate
10 2015-03-27

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