MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX CLEAR ORAL SOFT SEAL CUFF; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/136/055
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.E1 - initial reporter last name unknown.E1 - initial reporter email.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that there was an air leak from the pie red balloon.There was no patient involvement and no patient harm reported.
Additional Manufacturer Narrative
Investigation summary: the returned sample was received in used condition and in a plastic bag.The returned sample was visually inspected at 12¿ to 16¿ and normal conditions of illumination according to the inspection procedure (b)(4).During visual inspection no damage or other defects were detected on the sample.A functional leak test was done.The sample failed to stay inflated.The sample was connected to the air equipment and submerged under water to detect any problem in the inflation system.The leak was confirmed in the cuff.

• Brand Name: PORTEX CLEAR ORAL SOFT SEAL CUFF
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19645446
• Report Number: 9617604-2024-00556
• Device Sequence Number: 6557887
• Product Code: BTR
• UDI-Device Identifier: 15019315021060
• UDI-Public: (01)15019315021060
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K931735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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: 100/136/055
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/23/2024
• 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
• Patient Sex: Unknown