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

Model Number IPN043751

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "[the filter] opens under traction of the coax tube which ventilates the patient".Multiple attempts made to customer for additional information has been unsuccessful.Patient information unknown at time of report.

Manufacturer Narrative

(b)(4).The actual device was returned and sent to the manufacturing site for evaluation.A visual exam was performed and it was observed that the product was detached.The complaint has been confirmed.The manufacturing site reports that the issue is supplier related and a non-conformance was opened to address the issue.

Event Description

It was reported that "[the filter] opens under traction of the coax tube which ventilates the patient".Multiple attempts made to customer for additional information has been unsuccessful.Patient information unknown at time of report.

• Brand Name: HUDSON ISO-GARD FILTER,STRAIGHT
• 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: 13844944
• MDR Text Key: 287593092
• Report Number: 8040412-2022-00056
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 04026704348008
• UDI-Public: 04026704348008
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K965016
• 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: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN043751
• Device Catalogue Number: 19212
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2022
• 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
• Treatment: NONE REPORTED; NONE REPORTED