FDA Adverse Event Malfunction Summary report: N

DISPOSIBLE CLEAR SWIVEL OXYGEN CONNECTOR

MDR report key: 1525481 · Received November 5, 2009

Report

Report Number
MW5013441
Event Type
Malfunction
Date Received
November 5, 2009
Date of Event
November 4, 2009
Report Date
November 5, 2009
Manufacturer
INSTRUMENTATION INDUSTRIES INC.
Product Code
BZA
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

A CLEAR PLASTIC O2 CONNECTOR -CHRISTMAS TREE- WAS FOUND TO BE SEALED AT THE END -MANUFACTURE DEFECT-. THIS BLOCKED THE OXYGEN FROM FLOWING THROUGH THE CONNECTOR. ALTHOUGH THE O2 -E-TANK- WAS TURNED ON, AND THE O2 GAUGE INDICATED 2 LPM FLOW THE CLEAR CONNECTOR'S OBSTRUCTED DISTAL END PREVENTED THE O2 FROM REACHING THE PATIENT. NORMALLY THE CENTER OF THE CONNECTOR IS HOLLOW ALLOWING THE O2 TO FLOW FROM THE TANK THROUGH THE O2 TUBING, TO THE PATIENT. THE PATIENT WAS BEING TRANSPORTED VIA WHEELCHAIR. HIS OXYGEN SATURATION BEGAN DROPPING SLOWLY, LIPS TURNED BLUISH AND HE WAS DIFFICULT TO AROUSE. O2 SAT WAS 76%. A NON-REBREATHER MASK WAS TRIED, WITHOUT EFFECT. THE DEFECTIVE CONNECTOR WAS IDENTIFIED AS THE PROBLEM, REPLACED WITH A PATIENT CONNECTOR AND THE PATIENT RETURNED TO O2 SATS IN THE 90'S. LOOKING AT THE CONNECTOR, IT APPEARS TO BE NORMAL. HOWEVER, THE END THAT THE O2 TUBING WOULD ATTACH TO -THE NIPPLE END- IS NOT HOLLOW. THE END IS SOLID, FILLED WITH CLEAR PLASTIC. THIS CLEAR PLASTIC APPEARS TO BE THE SAME MATERIAL AS THE REST OF THE CONNECTOR. NO EXTRA MATERIAL PROTRUDES FROM THIS END. IT IS FLAT, THUS MAKING THIS DEFECT EVEN MORE DIFFICULT TO NOTICE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DISPOSIBLE CLEAR SWIVEL OXYGEN CONNECTOR O2 CONNECTOR, "CHRISTMAS TREE CONNECTOR" BZA INSTRUMENTATION INDUSTRIES INC. SH 75-C P0906109

Patients

Seq Age Sex Outcome Treatment
1 65 YR