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

Catalog Number	101/860/090CZ
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.D4.Primary udi number: the primary di# has been used as the lot/serial information is unknown.H3.Reason device not evaluation by mfg: other, device was 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 information becomes available.
Event or Problem Description
It was stated in the report that the cuff had a pinhole, so the cuff pressure cannot be kept.The sample was available for investigation.The event occurred during infusion at the facility.There was a patient involvement, but no harm/adverse event reported.There was no disinfection or sterilization, and no infectious disease occurred.
Additional Manufacturer Narrative
Investigation summary: one used decontaminated sample was returned for investigation without its original packaging.Customer is claiming pinhole on the tracheostomy tube cuff which was detected during use.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.The sample was tested too under water and no pinhole was found.Based on results of testing the reported failure was not observed.No signal of similar customer complaints was identified.A device history record could not be completed as no lot number was received.

• Brand Name: PORTEX BLUSELECT SUCTIONAID TRACHEOSTOMY TUBE
• 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: 20684190
• Report Number: 3011237704-2024-00249
• Device Sequence Number: 7234793
• Product Code: BTO
• UDI-Device Identifier: 15019517076172
• UDI-Public: (01)15019517076172
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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 Catalogue Number: 101/860/090CZ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/11/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/10/2024
• 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