MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON HUMID-VENT FILTER COMPACT STRAIGHT; FILTER, BACTERIAL, BREATHING-C

Model Number	IPN043768
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during the pre-test, alert leakage".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did provide a video for evaluation.Based on the video, it was observed that bubbles were coming out from the filter, however further investigation could not be conducted to identify the root cause of leak.In the current manufacturing procedure, 100% visual inspection and leak testing is conducted after the assembly process; therefore, any defects would be detected prior to release from the manufacturing facility.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 a vailable information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "during the pre-test, alert leakage".No patient involvement reported.

• Brand Name: HUDSON HUMID-VENT FILTER COMPACT STRAIGHT
• Common Device Name: FILTER, BACTERIAL, BREATHING-C
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11794508
• Report Number: 8040412-2021-00140
• Device Sequence Number: 19844353
• Product Code: CAH
• UDI-Device Identifier: 04026704348022
• UDI-Public: 04026704348022
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: No Information
• Device Expiration Date: 09/28/2025
• Device Model Number: IPN043768
• Device Catalogue Number: 19402
• Device Lot Number: KMZ20K0224
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1