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

Model Number	IPN043751
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 8040412-2022-00056
• Device Sequence Number: 17146999
• Product Code: CAH
• UDI-Device Identifier: 04026704348008
• UDI-Public: 04026704348008
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K965016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 03/22/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown