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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CANNULA,OVER-THE-EAR W/FLARED NASAL PRO; CANNULA, NASAL, OXYGEN
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TELEFLEX MEDICAL HUDSON CANNULA,OVER-THE-EAR W/FLARED NASAL PRO; CANNULA, NASAL, OXYGEN Back to Search Results
Catalog Number 1104
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/14/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer reported the cannula was placed on the patient and the patient was transferred to another hospital, where the cannula was found kinked.It was reported that during the transfer, the patient's saturation did not easily increase, but there was no injury to the patient.It was unknown when the device became kinked.
 
Event Description
Customer reported the cannula was placed on the patient and the patient was transferred to another hospital, where the cannula was found kinked.It was reported that during the transfer, the patient's saturation did not easily increase, but there was no injury to the patient.It was unknown when the device became kinked.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the tube was kinked.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint was confirmed.Although the complaint was confirmed, there is not sufficient evidence to confirm this issue on the oxygen tube was originated during the manufacturing process.The customer complaint description states that the user does not know if the cannula had been kinked from the beginning or got kinked during the transfer of a patient.The root cause for the condition reported could not be identified.
 
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Brand Name
HUDSON CANNULA,OVER-THE-EAR W/FLARED NASAL PRO
Type of Device
CANNULA, NASAL, OXYGEN
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9774684
MDR Text Key191573180
Report Number3004365956-2020-00077
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 company representative,foreig
Type of Report Initial,Followup
Report Date 02/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number1104
Device Lot Number74F1901484
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2020
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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