MAUDE Adverse Event Report: SLICK SET CUFFED 7.0MM; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN040783
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "clinicians are able to intubate the patient just fine.After an hour they notice that the connector pops off our et tube".No patient injury or consequence reported.Patient condition unknown at time of report.
Additional Manufacturer Narrative
Qn#(b)(4).Additional information received from the customer indicates that patient was bagged with 100% oxygen and the et tube was not changed, only monitored.The patient did experience desaturation; however, there was no harm or injury to the patient.The customer has also reported the patient current condition as "expired".Several attempts were made to get additional information and further clarification; however, nothing was received at the time of this report.Investigation results are as follows: complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review could not be performed as the lot number reported by the customer is not a valid lot.The connector assembly features of the et tube were designed in such a way that the connector can be removed and connected back to the tube when the tube is required to be cut to length.There is a precaution stated in the ifu that the 15mm connector should be firmly seated in the tracheal tube to prevent disconnection during use.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "clinicians are able to intubate the patient just fine.After an hour they notice that the connector pops off our et tube".No patient injury or consequence reported.
Event or Problem Description
It was reported "clinicians are able to intubate the patient just fine.After an hour they notice that the connector pops off our et tube".No patient injury or consequence reported.
Additional Manufacturer Narrative
Qn# (b)(4).Corrected data: section d1: brand name corrected to slick set cuffed 7.0mm.Section d4: catalog# corrected to 170070.Section d4: udi# corrected to (b)(4).

• Brand Name: SLICK SET CUFFED 7.0MM
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• MDR Report Key: 11486333
• Report Number: 8040412-2021-00077
• Device Sequence Number: 3876954
• Product Code: BTR
• UDI-Device Identifier: 14026704340870
• UDI-Public: 14026704340870
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K961840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2021

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: No Information
• Device Model Number: IPN040783
• Device Catalogue Number: 170070
• Device Lot Number: 191T25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 04/14/2021; 04/14/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 04/23/2021; 09/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2019
• 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