MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HV TRACH; HUMID-VENT HEAT AND MOISTURE

Model Number	IPN044386
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported issue: trach vent hme does not come of the cannula.Cannula change was performed.There was no injury.
Event or Problem Description
Reported issue: trach vent hme does not come of the cannula.Cannula change was performed.There was no injury.
Additional Manufacturer Narrative
(b)(4).One actual sample was received.The complaint sample was received with cannula which does not belong to teleflex product.The sample was closely examined by visual inspection.Based on the returned sample provided, the connector area of trach vent having stretch mark that was cause by the larger size of cannula.Therefore, the trach vent was having difficulty with removal from the cannula after connection.15mm ring gauge test was conducted on the connector of the canula.The connector side of the canula is out of the specification according to iso 5356-1:2015.It is larger than 15mm.In current manufacturing procedure, iqc department will conduct sampling gauge test before release the part item to production.In production, 100% visual inspection at assembly area is conducted.Thus, any ineffective products will be culled out during this process.Therefore, it is very unlikely condition at the manufacturing area that the product having defect to be released for shipment.The customer complained that trach vent hme does not come off the cannula.Based on the gauge test conducted on returned sample, the connector of cannula is bigger and causing tight connection with trach vent.Since the canula does not belong to teleflex products, further investigation could not be performed.Therefore, this complaint could not be further verified.

• Brand Name: HV TRACH
• Common Device Name: HUMID-VENT HEAT AND MOISTURE
• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16489717
• Report Number: 8040412-2023-00093
• Device Sequence Number: 20562801
• Product Code: BYD
• UDI-Device Identifier: 04026704348145
• UDI-Public: 04026704348145
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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: IPN044386
• Device Catalogue Number: 41112
• Device Lot Number: KMZ21M0466
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2022
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown