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

Catalog Number	101/860/060CZ
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: month and year are known: day is unknown.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 cuff had shrunk greatly over time.This occurred during infusion.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H6.Investigation codes: updated.Investigation summary: one used decontaminated sample was returned for investigation.Customer is claiming that the cuff had shrunk greatly over time.Under visual inspection the sample appeared to be in good condition.During manufacturing process, the devices are 100% inflation tested, which includes inflating each device cuff and leaving for a 12-hour period.Reductions in pressure over this time are considered a failure and the device would be rejected.The inflation test was repeated on the received sample.It was confirmed that after 12 hours the cuff was still fully inflated, no cuff leak.Based on results of testing the reported failure was not observed and the root cause was not determined.No trend of similar customer complaints was identified.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: PORTEX BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY
• 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: 18979933
• Report Number: 3011237704-2024-00074
• Device Sequence Number: 6035526
• Product Code: BTO
• UDI-Device Identifier: 15019517076127
• UDI-Public: (01)15019517076127(17)271018(10)4242923
• 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,Followup
• Report Date (Section B): 04/25/2024

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 Catalogue Number: 101/860/060CZ
• Device Lot Number: 4242923
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2022
• 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