MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON HCH ASSY,AQUA+

Catalog Number 1571

Device Problems Break (1069); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)

Event Date 01/06/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the hme fell apart when attempting placement with a ventilator circuit.The patient safety was not jeopardized; however, there was a delay in establishing the humid ventilation circuit due to the hme having to be changed out.The patient condition is reported as fine.

Manufacturer Narrative

The device sample was not returned for evaluation at the time of this report.

Manufacturer Narrative

A device history record (dhr) review was performed and there were no issues found that could have contributed to the reported failure.All processes were executed according to standard operating methods.The sample was returned for evaluation.A visual exam was performed and it was found that the product was detached.Five samples from production were selected and subjected to a pull test.All samples were able to withstand the force applied during the testing.It is only when excessive force was used is when the products detached.Based on the investigation performed, the reported complaint could not be confirmed.The returned sample was detached, which could be a result of mishandling of the product, although this could not be confirmed.At the manufacturing facility, 100% leak testing during the assembly process and a 100% visual inspection at the packing area is conducted.Any defects such as that reported in the complaint would be detected prior to release.The root cause of the product detachment could not be determined.

Manufacturer Narrative

(b)(4).The sample was re-investigated and it was found that the sample showed evidence of improper welding.Based on this, the complaint was confirmed.A capa was opened to address the issue.

• Brand Name: HUDSON HCH ASSY,AQUA+
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC ; MY
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; kamunting; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 3788685
• MDR Text Key: 4442589
• Report Number: 8040412-2014-00017
• Device Sequence Number: 1
• Product Code: BTT
• 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,Distributor
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1571
• Device Lot Number: 201321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1