MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON HUMID-VENT COMPACT STRAIGHT; CONDENSER, HEAT AND MOISTURE

Catalog Number 19402

Device Problem Occlusion Within Device (1423)

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2016

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The customer alleges that airflow was being obstructed in the circuit.

Manufacturer Narrative

(b)(4).The actual complaint sample was not returned for evaluation; therefore, t(b)(4) pieces of the same catalog number in current production at the manufacturing facility were taken to test the reported defect.No defects were found on the samples.Drop testing was also conducted and all samples passed the test.The reported complaint could not be confirmed as the actual sample was not returned for evaluation.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

The customer alleges that airflow was being obstructed in the circuit.

• Brand Name: HUDSON HUMID-VENT COMPACT STRAIGHT
• Type of Device: CONDENSER, HEAT AND MOISTURE
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5708882
• MDR Text Key: 46889001
• Report Number: 8040412-2016-00120
• Device Sequence Number: 1
• Product Code: BYD
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/07/2016

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: 19402
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 06/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/26/2016
• 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