FLEXITRUNK INFANT NASAL TUBING BC191

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-04 for FLEXITRUNK INFANT NASAL TUBING BC191 manufactured by Fisher & Paykel Healthcare Limited.

Event Text Entries

[187408302] (b)(4). The complaint bc191 flexitrunk infant nasal tubing is currently en route to fisher & paykel healthcare (f&p) for evaluation to determine if our product caused or contributed to the reported event. We will provide a follow-up report upon completion of our investigation.
Patient Sequence No: 1, Text Type: N, H10


[187408323] A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the bc191 flexitrunk infant nasal tubing was found to be damaged before use. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611451-2020-00234
MDR Report Key9787778
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-04
Date of Report2020-02-05
Date Mfgr Received2020-02-05
Device Manufacturer Date2019-10-24
Date Added to Maude2020-03-04
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 ContactMS. FARANAK GOMAROONI
Manufacturer Street173 TECHNOLOGY DR., SUITE 100 IRVINE
Manufacturer CityCA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9494534000
Manufacturer G1FISHER & PAYKEL HEALTHCARE LIMITED
Manufacturer Street15 MAURICE PAYKEL PLACE EAST TAMAKI
Manufacturer CityAUCKLAND, 2013
Manufacturer CountryNZ
Manufacturer Postal Code2013
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLEXITRUNK INFANT NASAL TUBING
Generic NameBZO
Product CodeBZO
Date Received2020-03-04
Model NumberBC191
Catalog NumberBC191
Lot Number2100919669
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerFISHER & PAYKEL HEALTHCARE LIMITED
Manufacturer Address15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-04

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