MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. SLICK SET CUFFED 7.5MM; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN042742
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	05/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a medwatch report, "the 15mm bvm (bag-valve mask) adapter on the et tube (endotracheal) tube came off of the tube and would not stay in place after the patient was intubated".Additional information received states that "minor desaturation was noted with this patient due to adapter coming off, but only by a couple of points.The patient died shortly after arriving at the emergency department due to the external pacer being removed.Not sure as to why but to our best knowledge this was not a result of the et tube".Further questions were asked regarding the cause and circumstances of the patient's death but the customer stated that they did not have any further information.If information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn(b)(4).
Event or Problem Description
It was reported via a medwatch report, "the 15mm bvm (bag-valve mask) adapter on the et tube (endotracheal) tube came off of the tube and would not stay in place after the patient was intubated".Additional information received states that "minor desaturation was noted with this patient due to adapter coming off, but only by a couple of points.The patient died shortly after arriving at the emergency department due to the external pacer being removed.Not sure as to why but to our best knowledge this was not a result of the et tube".Further questions were asked regarding the cause and circumstances of the patient's death but the customer stated that they did not have any further information.If information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).Mw#5118133 the manufacturing site reports "there was no sample available for this complaint, therefore sample verification as per reported could not be conducted.Dhr also could not be provided as the lot number kme21k1410 was not found in the system, possible wrong lot number provided from complainant." 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.Corrected data: section e.1.-initial reporter name and address corrected.Section e.4.-corrected to 'yes' section g.2.-report source corrected to 'other - medwatch'.

• Brand Name: SLICK SET CUFFED 7.5MM
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17217930
• Report Number: 8040412-2023-00259
• Device Sequence Number: 19588960
• Product Code: BTR
• UDI-Device Identifier: 04026704319589
• UDI-Public: 04026704319589
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K780900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

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 Expiration Date: 09/28/2026
• Device Model Number: IPN042742
• Device Catalogue Number: 170075
• Device Lot Number: KME21K1410
• 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: 06/09/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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