MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON DUAL HEATED DUAL DRAIN

Catalog Number 880-36KIT

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2015

Event Type  malfunction  

Event Description

The customer alleges that the concha column was leaking.No pt injury reported.

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.Device history record (dhr) investigation of batch number (b)(4) did not show issues related to complaint.No nonconformity reports originated for lot in question that can be associated to the complaint reported.The product was assembled and inspected according to specifications.No corrective action can be established since the device sample or a picture of it is not available for eval.Customer complaint cannot be confirmed due to the lack of product sample or picture.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility nor is it being manufactured at the time.If the physical sample becomes available this complaint will be reopened.

• Brand Name: HUDSON DUAL HEATED DUAL DRAIN
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo, tamaulipas ; MX
• Manufacturer Contact: margie burton, rn, ra ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4474996
• MDR Text Key: 5404215
• Report Number: 3004365956-2015-00052
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/08/2015

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: Health Professional
• Device Catalogue Number: 880-36KIT
• Device Lot Number: 74K1402731
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2015
• Initial Date FDA Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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