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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL CANNULA,1103 W/25' STAR LUMEN TBG; CANNULA, NASAL, OXYGEN
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TELEFLEX MEDICAL CANNULA,1103 W/25' STAR LUMEN TBG; CANNULA, NASAL, OXYGEN Back to Search Results
Catalog Number 1812
Device Problem Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/05/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer complaint reported as: "the pipe is bend, so when the machine is started the cannula come's out due to pressure." no patient harm was reported.
 
Event Description
Customer complaint reported as: "the pipe is bend, so when the machine is started the cannula come's out due to pressure".No patient harm was reported.
 
Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
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Brand Name
CANNULA,1103 W/25' STAR LUMEN TBG
Type of Device
CANNULA, NASAL, OXYGEN
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9899741
MDR Text Key190139725
Report Number3004365956-2020-00094
Device Sequence Number1
Product Code CAT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 03/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date06/04/2023
Device Catalogue Number1812
Device Lot Number74F1800147
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
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