MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. FLEXI-SET UNCUFFED 3.5MM; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	506535
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Airway Obstruction (1699); Cardiac Arrest (1762); Low Oxygen Saturation (2477); Respiratory Arrest (4461)
Date of Event	08/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the "bedside rn doing morning cares and meds.Patient is intubated, sedated and paralyzed in the bed.Patient started to [desaturate] from 98-89%.Rn assessed patient, and vent settings, in prepping to suction patient, rn saw ett connector was broken off in the bed and patient quickly [desaturated] to 40%.Rn started to mask bag over the ett @ 100% while calling for full assist, continuing to bag.Patient went into full cardiac arrest, compressions started".Additional information states, this piece actually broke and the small plastic piece got lodged in the airway causing an obstruction.It did not disconnect".Further information received states, "uncertain as to how it broke, while the nurse was providing care, found the broken piece in the bed.Patient was having am care done".The current status of the patient is reported as "stable".
Additional Manufacturer Narrative
(b)(4).The customer report of a "broke - connector" was not able to be confirmed by visual inspection of the customer supplied photos.Visual inspection was conducted based on the sap photo sample.Comparison was made between the sample shown in the photo and a teleflex connector.Based on the visual inspection, the shape and design of the connector from customer complaint photo is completely different from the actual connector used in pvca production line, teleflex kamunting.It has been confirmed that the above reported connector as per sap picture is not a component/part used in kamunting manufacturing plant.Although with the broken connector picture from sap, the defect mode could not be confirmed due to the reported complaint connector is not part of teleflex kamunting manufacturing plant.A device history record review was performed, and no relevant findings were identified.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the "bedside rn doing morning cares and meds.Patient is intubated, sedated and paralyzed in the bed.Patient started to [desaturate] from 98-89%.Rn assessed patient, and vent settings, in prepping to suction patient, rn saw ett connector was broken off in the bed and patient quickly [desaturated] to 40%.Rn started to mask bag over the ett @ 100% while calling for full assist, continuing to bag.Patient went into full cardiac arrest, compressions started".Additional information states, this piece actually broke and the small plastic piece got lodged in the airway causing an obstruction.It did not disconnect".Further information received states, "uncertain as to how it broke, while the nurse was providing care, found the broken piece in the bed.Patient was having am care done".The current status of the patient is reported as "stable".

• Brand Name: FLEXI-SET UNCUFFED 3.5MM
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17665080
• Report Number: 8040412-2023-00340
• Device Sequence Number: 17918443
• Product Code: BTR
• UDI-Device Identifier: 04026704547685
• UDI-Public: 04026704547685
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K961840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2025
• Device Catalogue Number: 506535
• Device Lot Number: KME21A2809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 5 MO
• Patient Sex: Female
• Patient Weight: 4 KG