MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET, LONG LENGTH; ADULT CONVENTIONAL CIRCUIT

Catalog Number 1613

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2013

Event Type  malfunction  

Event Description

The complaint was reported as: the customer alleges that the circuit is leaking when tested prior to use.No report of a pt injury.

Manufacturer Narrative

A visual, dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.The assembly process and mfg procedure for catalog #1613 were reviewed and no finding related to the reported issue were found.The description of the complaint states that the product corresponds to lot number pro20021067 but the lot provided is not valid to (b)(6) facility.No corrective action can be established since the sample is not available to perform an investigation and determine the source of defect reported.This customer complaint can not be confirmed due to the lack of product sample to perform an investigation and determine the source of defect reported.

• Brand Name: HUDSON VENTILATOR TUBING SET, LONG LENGTH
• Type of Device: ADULT CONVENTIONAL CIRCUIT
• Manufacturer (Section D): TELEFLEX MEDICAL; nuevo laredo, tamaulipas ; MX
• Manufacturer (Section G): TELEFLEX; ave. industrias no.5954; parque industrial finsa; nuevo laredo, tamaulipas 8827 5; MX 88275
• Manufacturer Contact: margie burton, specialist ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3663177
• MDR Text Key: 4340541
• Report Number: 3004365956-2013-00246
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/08/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1613
• Device Lot Number: PR0200021067
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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