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

(b)(4).

Manufacturer Narrative

Qn#(b)(4).The actual device was not returned; however, the customer provided two representative samples for evaluation.The samples were visually inspected and no defects were observed.The samples were found to be assembled correctly.The manufacturer reports that in the current manufacturing procedure, 100% leak testing is performed during the assembly process, along with a sampling pull test and 100% visual inspection at packing area; therefore, any defective devices would be detected prior to release from the manufacturing facility.A device history record review was performed and no relevant findings were identified.Without the actual 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.Corrected data: section h.6.- medical device problem code corrected from (b)(6).

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: 15224044
• MDR Text Key: 303741455
• Report Number: 8040412-2022-00228
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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