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

Model Number IPN043749

Device Problem Material Separation (1562)

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

Event Date 02/28/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "when the patient was connected to the mobile ventilator, it was noticed that the filter had come apart".No patient injury or harm reported.Patient condition reported as "fine".

Event Description

It was reported that "when the patient was connected to the mobile ventilator, it was noticed that the filter had come apart".No patient injury or harm reported.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided a photo for evaluation.A visual exam was performed on the photo and it was observed that the filter was split in two.The complaint has been confirmed.A device history record review was performed and no relevant findings were identified.The manufacturing site reports that the issue is supplier related and a non-conformance was opened to address the issue.

• 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
• MDR Report Key: 13905393
• MDR Text Key: 288628831
• Report Number: 8040412-2022-00054
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K965016
• 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: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• 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: KMH21D0170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2022
• 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
• Patient Sex: Male