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

Model Number IPN043749

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 05/19/2022

Event Type  malfunction  

Event Description

It was reported that: "while using the filter, the filter opened in 2 pieces and you could touch the inside.Due to the yellow sticker, it was masked, and it took a while that they found out where the leak came from".No patient injury or harm reported.Patient condition reported as "fine".

Manufacturer Narrative

Qn#(b)(4).

Manufacturer Narrative

(b)(4).The sample was not returned for evaluation.The manufacturing site reports that based on the lot number of the product, it was determined that the issue is supplier related and a non-conformance was opened to address the issue.

Event Description

It was reported that: "while using the filter, the filter opened in 2 pieces and you could touch the inside.Due to the yellow sticker, it was masked, and it took a while that they found out where the leak came from".No patient injury or harm reported.Patient condition reported as "fine".

• 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: 14798406
• MDR Text Key: 301653103
• Report Number: 8040412-2022-00153
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 05/30/2022

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 Model Number: IPN043749
• Device Catalogue Number: 19211
• Device Lot Number: KMH21H0038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 07/19/2022
• Supplement Dates FDA Received: 07/19/2022
• 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
• Treatment: VENTILATOR.; VENTILATOR.