MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET,LONG LENGTH; CIRCUIT,BREATHING(W/CONNECTOR)

Catalog Number 1613

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It was reported by the customer that the actual device involved in this complaint was "misplaced or thrown away".A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned.However, samples of current production ((b)(4)) were reviewed and inspected functionally according to (b)(4) and no issues were found.A device history record investigation shows that the product was assembled and inspected according to our specifications.No corrective actions can be established at this moment since the device sample is not available for evaluation.The device sample is necessary to perform a proper investigation in order to determine the root cause and any corresponding corrective actions.Customer complaint cannot be confirmed based only on the information provided.If the device becomes available at a later date this complaint will be re-opened.

Event Description

Customer complaint alleges the ventilator failed due to excessive leak between circuit and expiratory cassette.Alleged defect was detected during a pre-use check.It was reported that product was not used on patient.No report of delay in treatment.

• Brand Name: HUDSON VENTILATOR TUBING SET,LONG LENGTH
• Type of Device: CIRCUIT,BREATHING(W/CONNECTOR)
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 6310268
• MDR Text Key: 66772092
• Report Number: 3004365956-2017-00064
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1613
• Device Lot Number: 74K1601401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2017
• Initial Date FDA Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OVP VENTILATOR