UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-12 for UNKNOWN manufactured by Unknown.

Event Text Entries

[77314611]
Patient Sequence No: 1, Text Type: N, H10


[77314612] Nurse removed iv catheter. The end catheter piece that goes into the vein became detached from the iv lock and stayed in the patient. The nurse had to remove the piece.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6633296
MDR Report Key6633296
Date Received2017-06-12
Date of Report2017-05-03
Date of Event2015-09-09
Report Date2017-05-03
Date Reported to FDA2017-05-03
Date Reported to Mfgr2017-05-03
Date Added to Maude2017-06-12
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN
Generic NameDUAL LUMEN IV LOCK
Product CodeEYB
Date Received2017-06-12
Model NumberUNKNOWN
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
OperatorNURSE
Device AvailabilityY
Device Age1 DY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
10 2017-06-12

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