MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON ISO GARD FILTER; BREATHING CIRCUIT BACTERIAL FILTER

Model Number IPN043752

Device Problems Material Separation (1562); Material Split, Cut or Torn (4008)

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

Event Date 01/10/2022

Event Type  malfunction  

Event Description

It was reported that "several times, when removing the respirator tube, the filter splits and brakes".The filters were replaced.No injury or harm reported.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(6).The sample was not returned for evaluation; therefore, ten pieces of the same product code were selected from current production at the manufacturing facility.The samples were visually inspected and no defects were observed.In addition to the visual exam, leak testing was performed on the production samples.No issues were encountered.All ten samples passed the testing.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.

Event Description

It was reported that "several times, when removing the respirator tube, the filter splits and brakes".The filters were replaced.No injury or harm reported.Patient condition reported as "fine".

• Brand Name: HUDSON ISO GARD FILTER
• Type of Device: BREATHING CIRCUIT BACTERIAL FILTER
• 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: 13514936
• MDR Text Key: 289352954
• Report Number: 8040412-2022-00035
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN043752
• Device Catalogue Number: 19212T
• Device Lot Number: KMZ21J0403
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2022
• 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