MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON TRACH-VENT+,CLEAN; HUMID-VENT HEAT AND MOISTURE

Model Number	IPN044418
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the filter was connected to a tracheotomy tube.The filter did not fit into the cannula.The attachment was loose, the filter was hanging down and thus oxygenation was impossible.It was then necessary to change the cannula to connect the filter".Additional information received stated that the patient did not experience any desaturation.The device was changed and there was no consequence for the patient.No patient harm or injury reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: "the filter was connected to a tracheotomy tube.The filter did not fit into the cannula.The attachment was loose, the filter was hanging down and thus oxygenation was impossible.It was then necessary to change the cannula to connect the filter".Additional information received stated that the patient did not experience any desaturation.The device was changed and there was no consequence for the patient.No patient harm or injury reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned a trach-vent filter, along with a tracheostomy tube.A visual exam was performed and it was observed that the tracheostomy tube is not a teleflex product.No defects were observed on the trach-vent filter.The manufacturing site reports "15mm plug gauge test was conducted on the connector of the sample, the connector side is in the specification according to iso 5356-1:2015.In current manufacturing procedure, incoming quality check (iqc) department shall 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 complaint could not be confirmed.

• Brand Name: HUDSON TRACH-VENT+,CLEAN
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14605523
• Report Number: 8040412-2022-00135
• Device Sequence Number: 5065082
• Product Code: BYD
• UDI-Device Identifier: 04026704348176
• UDI-Public: 04026704348176
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2022

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
• Device Expiration Date: 04/28/2026
• Device Model Number: IPN044418
• Device Catalogue Number: 41312
• Device Lot Number: KMZ21E0571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2021
• 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