MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX TUBES BLUSELECT SUCTIONAID; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/860/085
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that air escaped from the cuff.When the cuff was before using it, the cuff deflated.During the patient's intubation, the cuff seemed to be deflated, making it easier for the tube to fall out.There was no patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H3: other; device 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.
Additional Manufacturer Narrative
D9 - date returned to mfg; 1/2/2024.H3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One used decontaminated device sample was received for investigation without its original packaging.Under visual inspection the sample appeared to be in good condition.An inflation test was performed on the received sample.It was confirmed that after twelve (12) hours the cuff was still fully inflated.The complaint was not confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No action taken and no trend of similar customer complaints was identified.
Additional Manufacturer Narrative
D4 was corrected.**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 CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18384542
• Report Number: 3011237704-2023-00014
• Device Sequence Number: 19522964
• Product Code: BTO
• UDI-Device Identifier: 15019517076165
• UDI-Public: (01)15019517076165(17)280223(10)4310532
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2024

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 Model Number: 101/860/085
• Device Catalogue Number: 101/860/085CZ
• Device Lot Number: 4310532
• 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: 11/27/2023
• Supplement Date Received by Manufacturer: 01/24/2024; 01/24/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/20/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• 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 Sex: Unknown