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

Model Number	101/870/070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: month and year of event have been provided; day is unknown.D4: lot number, expiration date and h4: device manufacture date are unknown, no information has been provided 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 during patient use there was air leakage from the cuff and its use was discontinued.The event occurred late (b)(6) 2023.There was no patient harm/adverse event reported.
Additional Manufacturer Narrative
H6 evaluation codes: updated.Device evaluation: one used decontaminated sample was returned for investigation.Under visual inspection the sample appeared to be in good condition.The inflation testing was repeated on the received sample.It was confirmed that after 12 hours the cuff was still fully inflated.The complaint could not be duplicated or confirmed.Based on results of testing the reported failure was not observed.No trend of similar customer complaints was identified.No lot number was provided, therefor no device history report (dhr) review could be completed.
Additional Manufacturer Narrative
D4 was corrected as we do not have the information to create a full udi.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; olomoucka 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18314415
• Report Number: 3011237704-2023-00001
• Device Sequence Number: 20362282
• Product Code: BTO
• UDI-Device Identifier: 15019517077988
• UDI-Public: 15019517077988
• 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: Non-Healthcare Professional
• 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: 101/870/070
• Device Catalogue Number: 101/870/070CZ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/12/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 01/08/2024; 01/08/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 02/06/2024; 07/22/2024
• 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
• Patient Sex: Unknown