MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX BLUSELECT PLAIN INNER CANNULA; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/856/080
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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 cannula was not clicking into the trach as it should.The event occurred before patient use, and no patient harm/adverse event was reported.
Additional Manufacturer Narrative
While performing a review of complaint file (b)(4), it was discovered that the file was inadvertently assessed as reportable.There was no patient death, no serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.Report reference number 9617604-2024-00647 is no longer considered reportable, please disregard any reports associated with it.

• Brand Name: PORTEX BLUSELECT PLAIN INNER CANNULA
• Common Device Name: TUBE, TRACHEOSTOMY (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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19973576
• Report Number: 9617604-2024-00647
• Device Sequence Number: 7057372
• Product Code: BTO
• UDI-Device Identifier: 15019517077797
• UDI-Public: (01)15019517077797(17)281016(10)4435052
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: 101/856/080
• Device Lot Number: 4435052
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2023
• 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 Age: 59 YR
• Patient Sex: Unknown