* 109850

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-08 for * 109850 manufactured by Linde Gas North America Llc.

Event Text Entries

[3455689] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3113352
MDR Report Key3113352
Date Received2013-05-08
Date of Report2013-05-08
Date of Event2013-05-02
Report Date2013-05-08
Date Reported to FDA2013-05-08
Date Reported to Mfgr2013-05-15
Date Added to Maude2013-05-15
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameCYLINDER, COMPRESSED GAS
Product CodeECX
Date Received2013-05-08
Model Number*
Catalog Number109850
Lot Number*
ID Number*
OperatorNURSE
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerLINDE GAS NORTH AMERICA LLC
Manufacturer Address2045 E AURORA RD TWINSBURG OH 44087 US 44087


Patients

Patient NumberTreatmentOutcomeDate
10 2013-05-08

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