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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 (W CONNECTO
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TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET,LONG LENGTH; CIRCUIT, BREATHING (W CONNECTO Back to Search Results
Catalog Number 1613
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/28/2018
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 or a picture of the alleged defect was not provided at the time of this report.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.To perform a thorough investigation and determine the source of alleged defect reported it is necessary to evaluate the sample involved in this complaint.Customer complaint cannot be confirmed based only on the information provided.Root cause is unknown.No corrective actions can be assigned at this time.If the sample becomes available this report will be updated with the evaluation results.
 
Event Description
Customer complaint alleges "vent check was performed in the department.Circuit did not pass leak test.The circuit was replaced with another 1613 and passed." alleged issue reported as detected during pre-test prior to a patient use.There was no report of patient impact or consequence.
 
Manufacturer Narrative
(b)(4).One (1) ventilator tubing set, long length, product code 1613, 6 feet long was received for investigation.No visual signs of abuse/misuse/damage were noted.The 1613 ventilator tubing set, long length was placed on a calibrated leak tester.Approximately 15 inches from the patient "y", ventilator side, is what appears to be a very clean, multiple "blade slices/cuts" on top of multiple tubing ribs.Once the tube set was submerged into a bath of water with the prescribed amount of air pressure, a profuse leak was discovered over approximately three (3) inches of the tubing via bubbling.The leak was so profuse a leak value could not established by the leak tester.The leak rate specification is governed by iso 5367, 2014, annex e, which specifies an adult circuit under 60 +- 3 cmh2o of air pressure, cannot exceed a leak rate greater than 70 ml/min.Based on the magnified pictures taken, the damage (cut) does not appear to have been caused by a manufacturing process.The cut is across the top of the ribs.Based on historical findings, manufacturing related leaks do not appear in the form of a slices/cuts.This damage appears to have been caused during use.It should also be noted that all circuit tubing is 100% inspected and leak tested prior to release from the manufacturing facility; thus any defects would be detected.
 
Event Description
Customer complaint alleges "vent check was performed in the department.Circuit did not pass leak test.The circuit was replaced with another 1613 and passed." alleged issue reported as detected during pre-test prior to a patient use.There was no report of patient impact or consequence.
 
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Brand Name
HUDSON VENTILATOR TUBING SET,LONG LENGTH
Type of Device
CIRCUIT, BREATHING (W CONNECTO
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 Key7619032
MDR Text Key111652697
Report Number3004365956-2018-00194
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number1613
Device Lot Number74A1802056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/17/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
VENTILATOR
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