PRO-VENT PLUS ABG KIT 4695

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-24 for PRO-VENT PLUS ABG KIT 4695 manufactured by Sims.

Event Text Entries

[22517] Performed abg on pt, removed needle and capped syringe with filter. Proceeded to remove air bubble by pressing plunger when blood squirted directly into face and into left eye. After incident, found small hole in syringe.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1009563
MDR Report Key34432
Date Received1996-07-24
Date of Report1996-07-15
Date of Event1996-07-12
Date Added to Maude1996-07-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePRO-VENT PLUS ABG KIT
Generic NameARTERIAL BLOOD GAS KIT
Product CodeLBT
Date Received1996-07-24
Returned To Mfg1996-07-15
Catalog Number4695
Lot Number605441
Device Expiration Date1999-05-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key35790
ManufacturerSIMS
Manufacturer Address15 KIT ST KEENE NH 03431 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1996-07-24

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