BALLARD CLOSED SUCTION CATHETER, ELBOW, WET PAK, NEONATAL/PEDIATRIC 8293J 109956901

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-01-30 for BALLARD CLOSED SUCTION CATHETER, ELBOW, WET PAK, NEONATAL/PEDIATRIC 8293J 109956901 manufactured by Avanos Medical Inc..

MAUDE Entry Details

Report Number8030647-2020-00004
MDR Report Key9646521
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-01-30
Date of Report2020-02-13
Date of Event2020-01-08
Date Mfgr Received2020-01-31
Date Added to Maude2020-01-30
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. LISA CLARK
Manufacturer Street5405 WINDWARD PARKWAY
Manufacturer CityALPHARETTA GA 30004
Manufacturer CountryUS
Manufacturer Postal30004
Manufacturer Phone4704485444
Manufacturer G1AVENT S DE RL DE CV
Manufacturer StreetCARRETERA INTERNACIONAL SALIDA NORTE NO. 1053
Manufacturer CityMAGDALENA, CP
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBALLARD CLOSED SUCTION CATHETER, ELBOW, WET PAK, NEONATAL/PEDIATRIC
Generic NameVAP CLOSED SUCTION CATHETERS & ACCESSORIES
Product CodeBSY
Date Received2020-01-30
Returned To Mfg2020-01-31
Model Number8293J
Catalog Number109956901
Lot NumberM19099T402
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerAVANOS MEDICAL INC.
Manufacturer Address5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-30

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