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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during mask ventilation, it is detected that air is leaking out of the filter.On closer inspection, you can see that the filter has opened in the joint".It was reported that the filter was replaced.No patient injury or harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
(b)(4).The actual sample 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 detached.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 and pull testing were also 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.Based on review of the photo, the complaint was confirmed.It is possible that the filter came apart due to high force applied or mishandling by the user.In the current manufacturing procedure, 100% leak testing during the assembly process and 100% visual inspection at the packing area is conducted.Thus, any defective products will be identified prior to release from the manufacturing facility.Without the 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 or Problem Description
It was reported that "during mask ventilation, it is detected that air is leaking out of the filter.On closer inspection, you can see that the filter has opened in the joint".It was reported that the filter was replaced.No patient injury or harm reported.Patient condition reported as "fine".

• 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: 13333935
• Report Number: 8040412-2022-00006
• Device Sequence Number: 14663298
• Product Code: CAH
• UDI-Device Identifier: 04026704348008
• UDI-Public: 04026704348008
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 12/30/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2025
• Device Model Number: IPN043751
• Device Catalogue Number: 19212
• Device Lot Number: KMZ21A0538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown