MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUMID VENT PEDI; CONDENSER, HEAT AND MOISTURE

Model Number IPN041365

Device Problem Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use on a patient, "plastic wasn't removed from tube and catching on one and second plastic was not removed in the slightest way and blocking the air coming through".As a result, the filter was changed out for another.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).The additional information received on 06oct2023 reported that there was no clear evidence of crystallization, and the patient side sampling port was blocked.The patient was breathing spontaneously, and the filter was connected to the lma, pointed upwards.The reported complaint was confirmed based upon the investigation of the returned sample.An actual sample was received with open package for evaluation.The sample was closely examined by visual inspection which revealed that the luer port of the product was occluded by the housing material.A device history record review was performed, and no relevant findings were identified.The root cause was determined as supplier related.Further actions and were initiated under teleflex quality systems to evaluate this issue.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that during use on a patient, "plastic wasn't removed from tube and catching on one and second plastic was not removed in the slightest way and blocking the air coming through".As a result, the filter was changed out for another.No patient harm or injury.The patient status is reported as "fine".

• Brand Name: HUMID VENT PEDI
• Type of Device: CONDENSER, HEAT AND MOISTURE
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17744913
• MDR Text Key: 323393832
• Report Number: 8040412-2023-00348
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

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 Model Number: IPN041365
• Device Catalogue Number: 11012T
• Device Lot Number: KMZ23B0263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2023
• 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