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

Model Number	IPN043768
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that prior to use while assembling the tubing, the filter does not stay attached to the tubing and disconnects from the whisper swivel valve easily, even if the tubing is not moved.Additional information received states that the filters are compatible with the swivel valve.No patient involvement.
Additional Manufacturer Narrative
(b)(4).A representative sample was returned to investigation site for evaluation.The device was reviewed as part of the investigation.The device was visually inspected where no issues were found.Functional testing was conducted on the representative sample through a gauge test and the connector was found to be within specification.In current manufacturing practice, all devices are subjected to a 100% visual inspection.Any devices which show defects are removed from the production line.A device history record (dhr) review was conducted and no issues that could have contributed to the reported event were identified.The manufacturing related root cause of the reported event could not be as the returned representative sample was found to be in specification and without issue.Teleflex will continue to monitor and trend for complaints of this nature.The associated mdr numbers identified were 8040412-2023-00197, 8040412-2023-00198 and 8040412-2023-00221.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that prior to use while assembling the tubing, the filter does not stay attached to the tubing and disconnects from the whisper swivel valve easily, even if the tubing is not moved.Additional information received states that the filters are compatible with the swivel valve.No patient involvement.

• Brand Name: HUMID-VENT FILTER COMPACT 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16913179
• Report Number: 8040412-2023-00222
• Device Sequence Number: 2189260
• Product Code: CAH
• UDI-Device Identifier: 04026704348022
• UDI-Public: 04026704348022
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

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 Model Number: IPN043768
• Device Catalogue Number: 19402
• Device Lot Number: KMZ22K0067
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• 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