MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX MAXILLO FACIAL NASAL SOFT SEAL CUFF, 6.0MM; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/133/060
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 - other: device has not been returned to date.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 the balloon was punctured even before being used.The malfunction was identified in the pre-use test before placement by the doctor.There is a sample available for evaluation.There was no patient involvement, harm or adverse event reported.
Additional Manufacturer Narrative
D9: date returned to mfg.: 4/30/2024.H3 and h6.Evaluation codes: updated.Two (2) device samples were received inside the original package; the package was unsealed.Broken cuff was observed in both samples.The complaint was confirmed.The root cause was unknown.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: PORTEX MAXILLO FACIAL NASAL SOFT SEAL CUFF, 6.0MM
• 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: 18861654
• Report Number: 9617604-2024-00210
• Device Sequence Number: 3307058
• Product Code: BTR
• UDI-Device Identifier: 15019315020339
• UDI-Public: (01)15019315020339(17)270510(10)4279655
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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: 100/133/060
• Device Lot Number: 4279655
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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