MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX TUBES BLUSELECT SUCTIONAID; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/810/080
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: b3: date of event is unknown; no information has been provided to date.D3, g1,2 email is: regulatory.Responses@icumed.Com.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 a patient had two (2) cannulas delivered, and both were found to be faulty (broken) at opening and unable to be used.No patient injury or clinical affects was reported and the outcome was reported as resolved.(b)(6) and (b)(6) represent the same patient.
Additional Manufacturer Narrative
Email is: regulatory.Responses@icumed.Com.H6 - evaluation codes: updated.Device evaluation: one device was returned for investigation.Under visual inspection it was noticed that the inflation line was detached from pilot balloon as reported by customer.The complaint was confirmed.This was attributed to a supplied item fault.This issue will continue to be monitored and further actions taken accordingly.
Additional Manufacturer Narrative
**udi related data quality updates only**.

• Brand Name: PORTEX TUBES BLUSELECT SUCTIONAID
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18326511
• Report Number: 3012307300-2023-11063
• Device Sequence Number: 7520308
• Product Code: BTO
• UDI-Device Identifier: 15019517076301
• UDI-Public: (01)15019517076301(11)220712(17)270613(10)4230143
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2024

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: Lay User/Patient
• Device Model Number: 101/810/080
• Device Catalogue Number: 101/810/080CZ
• Device Lot Number: 4230143
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 12/19/2023; Not provided
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/13/2024; 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown