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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CANNULA,OVER-THE-EAR; CANNULA, NASAL, OXYGEN
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TELEFLEX MEDICAL HUDSON CANNULA,OVER-THE-EAR; CANNULA, NASAL, OXYGEN Back to Search Results
Catalog Number 1103
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/08/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not received by the manufacturer at the time of this report.A device history record review could not be conducted since the lot number was not provided.In order to perform a proper and thorough investigation to confirm the alleged defect, and determine the source, it is necessary to evaluate the sample involved on this complaint.Customer complaint cannot be confirmed based only on the information provided.No corrective action can be established at this time.If device sample becomes available at a later date this complaint will be updated accordingly.
 
Event Description
Customer complaint alleges "during a procedure they heard a popping sound, a few seconds later followed by another loud popping sound.With the second pop the nasal cannula separated at this junction." customer reported there was no injury to the patient.
 
Manufacturer Narrative
Qn#: (b)(4).The sample was returned for evaluation.A visual inspection was performed and it was observed that the tubing did not pop off from the cannula as reported in the complaint.It was observed, however, that a part of the tubing was broken off inside the cannula.There is not sufficient evidence to assure that this issue originated during the manufacturing process; therefore, the complaint could not be confirmed.
 
Event Description
Customer complaint alleges "during a procedure they heard a popping sound, a few seconds later followed by another loud popping sound.With the second pop the nasal cannula separated at this junction." customer reported there was no injury to the patient.
 
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Brand Name
HUDSON CANNULA,OVER-THE-EAR
Type of Device
CANNULA, NASAL, OXYGEN
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo 88275
MX   88275
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key7053626
MDR Text Key93256788
Report Number3004365956-2017-00412
Device Sequence Number1
Product Code CAT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number1103
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received12/19/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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