MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON FILTER ARIOS; FILTER, BACTERIAL, BREATHING-C

Model Number IPN043749

Device Problems Leak/Splash (1354); Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2022

Event Type  malfunction  

Event Description

It was reported that: "they notify the electromedicine colleague from the operating room that the respirator has a leak.".

Manufacturer Narrative

Qn#(b)(4).

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.Corrected data: section h.6.- medical device problem code corrected from a0504 to a050402.

Event Description

It was reported that: "they notify the electromedicine colleague from the operating room that the respirator has a leak.Everything works fine and it is found that the filter is moving around the union "it is not well sealed" causing the leak." the issue was detected prior to use on a patient.

• Brand Name: HUDSON FILTER ARIOS
• Type of Device: FILTER, BACTERIAL, BREATHING-C
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15224102
• MDR Text Key: 302591567
• Report Number: 8040412-2022-00231
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN043749
• Device Catalogue Number: 19211
• Device Lot Number: KMH21L0225
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2022
• 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