ARGYLE 461008E

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for ARGYLE 461008E manufactured by Cardinal Health, Inc..

Event Text Entries

[183895222] Rn opened 5fr ng tube for placement in nicu patient. Upon inspection for measurement, rn noted that the tube was missing the printed markings on the tube. Tubing and packaging was saved and new tube was obtained and used. The device was never used on patient. It was found prior to use on infant.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9847361
MDR Report Key9847361
Date Received2020-03-18
Date of Report2020-01-27
Date of Event2020-01-27
Report Date2020-01-27
Date Reported to FDA2020-01-27
Date Reported to Mfgr2020-03-18
Date Added to Maude2020-03-18
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARGYLE
Generic NameGASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
Product CodePIF
Date Received2020-03-18
Model Number461008E
Catalog Number461008E
Lot Number1824727264
Device AvailabilityY
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH, INC.
Manufacturer Address15 HAMPSHIRE STREET BUILDING 5 MANSFIELD MA 02048 US 02048


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-18

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