FDA Adverse Event Malfunction Summary report: N

*

MDR report key: 3113352 · Received May 8, 2013

Report

Report Number
3113352
Event Type
Malfunction
Date Received
May 8, 2013
Date of Event
May 2, 2013
Report Date
May 8, 2013
Manufacturer
LINDE GAS NORTH AMERICA LLC
Product Code
ECX
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MI, US

Narratives

Description of Event or Problem · 1

STAFF HAD DIFFICULTY REMOVING THE CAP ON THE AGA LINDE HEALTHCARE OXYGEN E CYLINDER RESULTING IN SLIGHT DELAY OF ADMINISTERING OXYGEN DURING AN EMERGENCY EVENT. THE INCIDENT OCCURRED AROUND 0730 A.M. THE CAP ON THE OXYGEN NIPPLE HAD CHANGED FOR THE OXYGEN E-CYLINDERS THAT WE RECEIVE. THE OLDER CAP THAT WAS PREVIOUSLY RECEIVED WAS A SLICK BLACK CAP (STRUCTURED: FLEXIBLE WITH NO HOLE ON THE END) THAT FITTED ON THE REGULATOR/O2 NIPPLE AND WAS EASILY REMOVABLE. NOW IT IS A STURDY DARK GREY CAP (STRUCTURED: STURDY, NO HOLE ON THE END, WHICH ALLOWS AIRFLOW THROUGH THE CAP) THAT IS DIFFICULT TO REMOVE.======================MANUFACTURER RESPONSE FOR OXYGEN E-CYLINDER, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================THE NEW CAPS HAVE BEEN IN USE THE PAST 3 - 4 MONTHS.THE CHANGE IS DUE TO A SAFETY FEATURE (WILL NOT POP OFF WHEN VALVE IS OPENED) AND IS IN USE INDUSTRY WIDE.THE CAPS SHOULD PULL OFF EASILY WITH TWO FINGERS. THEY CAN BE TWISTED BUT IT'S NOT NECESSARY.THEY HAVE NOT HAD THIS ISSUE FROM ANY OTHER CUSTOMERS.HERE IS WHAT THE COMPLIANCE TEAM'S RESPONSE IS: THE CAPPING OF CYLINDER OPENINGS IS NOT GOING TO STOP. YOU CAN CONTACT YOUR CAP PLUGS REP AND SEE IF HE CAN PROVIDE YOU WITH A CAP THAT IS EASIER FOR THEM TO REMOVE. YOU CAN ALSO TELL THEM THAT WE ARE PROVIDING THEM A FINISHED DRUG PRODUCT AND THE CAPS ARE REQUIRED PER OUR INTERNAL PROCEDURES. IF YOU'D LIKE FURTHER INFORMATION ON THIS, PLEASE CALL 866-543-3427 AND FILE A FORMAL COMPLAINT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ADMINISTRATION OF OXYGEN DURING AN EMERGENCY SITUATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
202312 * CYLINDER, COMPRESSED GAS ECX LINDE GAS NORTH AMERICA LLC * *

Patients

Seq Age Sex Outcome Treatment
1 * AGA LINDE HEALTHCARE OXYGEN E CYLINDERS