MAUDE Adverse Event Report: TELEFLEX HUDSON 780-35 CIRCUIT W/ COLUMN; BREATHING CIRCUIT

Catalog Number 780-35KIT

Device Problem Misassembled (1398)

Patient Problem No Patient Involvement (2645)

Event Date 02/03/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the circuit had the limbs reversed.The alleged issue was detached prior to patient use.

Manufacturer Narrative

A visual and functional inspection of the product involved in the complaint could not be conducted since the product was not returned for evaluation.The device history record (dhr) of batch number 02l1302324 that belongs to catalog number 780-35kit has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance report (ncmr) were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.Based on similar complaints for "limbs reversed", a non-conformance has been issued in order to review current production, to identify a root cause, and implement corresponding corrective actions.

• Brand Name: HUDSON 780-35 CIRCUIT W/ COLUMN
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX; nuevo laredo ; MX
• Manufacturer Contact: kathy tarpley ; p.o. box 12600; durham, NC 27709 ; 9194334854
• MDR Report Key: 3727508
• MDR Text Key: 4324279
• Report Number: 3004365956-2014-00091
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/03/2014

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: 780-35KIT
• Device Lot Number: 02L1302324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2014
• Initial Date FDA Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1