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

Model Number IPN044418

Device Problem Connection Problem (2900)

Patient Problem Discomfort (2330)

Event Date 05/09/2022

Event Type  malfunction  

Event 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".

Manufacturer Narrative

Qn# (b)(4).

Event 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".

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
• Type of Device: 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
• MDR Text Key: 293456585
• Report Number: 8040412-2022-00135
• Device Sequence Number: 1
• Product Code: BYD
• UDI-Device Identifier: 04026704348176
• UDI-Public: 04026704348176
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 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 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
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 06/06/2022
• Supplement Dates Manufacturer Received: 06/30/2022
• Supplement Dates FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1