MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. SUPR SAFETY MAGIL CUF ET; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	112480025
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	05/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: patient's endotracheal tube does not have any numbers, therefore we can not tell if the ett is in proper position.The patient has large amount on secretions.Patient already has a history of airway edema along with difficult intubation.Upon xray, patient ett was at the clavicle.The measured 1.5cm from position of ett then pushed in 1.5cm with no xray to follow.Lma's were placed at patient bedside.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.Additiona information: the markings had been present but faded over time.
Event or Problem Description
It was reported that: patient's endotracheal tube does not have any numbers, therefore we can not tell if the ett is in proper position.The patient has large amount on secretions.Patient already has a history of airway edema along with difficult intubation.Upon xray, patient ett was at the clavicle.The measured 1.5cm from position of ett then pushed in 1.5cm with no xray to follow.Lma's were placed at patient bedside.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.Additional information: the markings had been present but faded over time.
Additional Manufacturer Narrative
(b)(4).The sample was returned to the manufacturer.The manufacturer reported: "one actual sample was returned.Visual inspection was conducted on the actual returned sample.There is sticky tape on the end of tube near the connector and under the tape, the printing is found faded.As per, pad printing procedure, rub test by using 100% ipa been conducted on each production batch at the beginning of the printing process.However, as per endotracheal tube manufacturing procedure, 100% inspection on printing was performed in manufacturing site.Hence, the complaint could not be confirmed as this defect mode could be detected during manufacturing process.Based on the investigation conducted, the defect mode on endotracheal tube does not have any numbers was match with complainant report.However, the defect cannot be confirmed, as the tube been passed the 100% visual inspection and rub test during manufacturing and such obvious defect can be detected and failed during the testing." teleflex will continue to monitor and trend on complaints of this na ture.Corrected data: correction d.4 udi (b)(4) was removed as the full udi number is unavailable as complainant did not report a lot number.

• Brand Name: SUPR SAFETY MAGIL CUF ET
• 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: 19643043
• Report Number: 8040412-2024-00155
• Device Sequence Number: 21001063
• Product Code: BTR
• UDI-Device Identifier: 14026704341495
• UDI-Public: 14026704341495
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K961837
• 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): 06/04/2024

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 Catalogue Number: 112480025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Age: 3 YR
• Patient Sex: Female