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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET,LONG LENGTH; CIRCUIT, BREATHING
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TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET,LONG LENGTH; CIRCUIT, BREATHING Back to Search Results
Catalog Number 1613
Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Date 12/28/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A visual, functional, and dimensional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report.No picture of the defect was provided.However material from the production line was inspected and no issues were detected that can lead to this customer complaint.A device history record review shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.In order to perform a proper investigation and determine the source of alleged defect reported, it is necessary to evaluate the device involved on this customer complaint.If defective sample becomes available at a later date this complaint will be updated.
 
Event Description
Customer complaint alleges "the user tried to connect the tubing with device but the connection was too loose to connect.Therefore, a new unit was used instead." there was no report of patient involvement.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and no issues were found.The reported complaint of an assembly/fitting issue at the wye connector cannot be confirmed.A device history record (dhr) review was performed on the product with no evidence to suggest a manufacturing related cause.
 
Event Description
Customer complaint alleges "the user tried to connect the tubing with device but the connection was too loose to connect.Therefore, a new unit was used instead." there was no report of patient involvement.
 
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Brand Name
HUDSON VENTILATOR TUBING SET,LONG LENGTH
Type of Device
CIRCUIT, BREATHING
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 Key6281063
MDR Text Key65900334
Report Number3004365956-2017-00034
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number1613
Device Lot Number74A1501734
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/08/2015
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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