HUDSON IN-LINE NEB TEE WITH VALVEM 1743

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-10 for HUDSON IN-LINE NEB TEE WITH VALVEM 1743 manufactured by Teleflex Medical.

Event Text Entries

[72543227] (b)(4)
Patient Sequence No: 1, Text Type: N, H10


[72543228] The customer alleges that there is a disconnection issue with the teleflex device and a vyaire product. No report of an injury or impact to the patient.
Patient Sequence No: 1, Text Type: D, B5


[75530631] (b)(4). The sample was returned for evaluation. A visual exam was performed and no defects were observed. A dimensional exam was also performed and the sample was found to be within specification. The returned sample could fit firmly with a nebulizer used at the manufacturing facility. Based on the investigation performed, the reported complaint of "device disconnects from nebulizer" could not be confirmed. There were no issues found with the returned sample.
Patient Sequence No: 1, Text Type: N, H10


[75530632] The customer alleges that there is a disconnection issue with the teleflex device and a vyaire product. No report of an injury or impact to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011137372-2017-00129
MDR Report Key6476249
Date Received2017-04-10
Date of Report2017-03-14
Date of Event2017-01-25
Date Mfgr Received2017-05-05
Date Added to Maude2017-04-10
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 Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal Code27560
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON IN-LINE NEB TEE WITH VALVEM
Generic NameTUBING, PRESSURE & ACCFESSORIES
Product CodeBYX
Date Received2017-04-10
Returned To Mfg2017-04-17
Catalog Number1743
Lot NumberUNKNOWN
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2017-04-10

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