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

Model Number	101/860/075
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: month and year of event have been provided; day is unknown.Device evaluation: one used decontaminated device sample was returned for investigation without its original packaging.Under visual inspection the sample appeared to be in good condition.A functional inflation test was performed on the received sample.It was confirmed that after twelve (12) hours the cuff was still fully inflated.The complaint could not be confirmed or replicated.A device history record (dhr) review could not be performed as the lot number was unknown.No action was taken, and no trend of similar customer complaints was identified.
Event or Problem Description
It was reported that "eight days after placement, the cuff was losing air.After replacement, the affected cuff was filled with air and left in place for six (6) hours, and air was slowly being released".This occurred during patient use, no patient harm/adverse event reported.

• Brand Name: PORTEX BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19052261
• Report Number: 3012307300-2024-02133
• Device Sequence Number: 7069017
• Product Code: BTO
• UDI-Device Identifier: 15019517076141
• UDI-Public: (01)15019517076141
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 101/860/075
• Device Catalogue Number: 101/860/075CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 04/05/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown