MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. GIBECK TRACH-VENT; 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	11/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trac vent's connector does not fit well to the tracheostomy tube.Due to this it is hard to connect and to disconnect the trac vent from the tracheostomy tube.No injury reported and a new trach vent was used.
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
It was reported that the trac vent's connector does not fit well to the tracheostomy tube.Due to this it is hard to connect and to disconnect the trac vent from the tracheostomy tube.No injury reported and a new trach vent was used.
Additional Manufacturer Narrative
Qn#(b)(4) five pieces of representative samples were received.The samples were closely examined by visual inspection.No issues were found.The complaint reported that the trac vent's connector does not fit well to the tracheostomy tube.Based on the returned samples provided, 15mm plug gauge test was conducted on the connector of the samples.The connector side is in the specification according to iso 5356-1-2015.In current manufacturing procedure, iqc department will conduct sampling gauge test before release of the part item to production.In production, 100% visual inspection at the assembly area is conducted.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 incident happened may have been due to the defect on the tracheostomy tube.Further study could not be conducted since the tracheostomy tube was not return for investigation.In conclusion, the complaint reported that the trac vent's connector does not fit well to the tracheostomy tube.But as per gauge test conducted on the returned samples, the connector met the specification.Hence, this complaint could not be confirmed.

• Brand Name: GIBECK TRACH-VENT
• 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: 15926628
• Report Number: 8040412-2022-00329
• Device Sequence Number: 5027173
• Product Code: BYD
• UDI-Device Identifier: 44026704348143
• UDI-Public: 04026704348145
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

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
• Operator of Device: Health Professional
• Device Model Number: IPN044386
• Device Catalogue Number: 41112
• Device Lot Number: KMZ22B0572
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2022
• 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