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

Catalog Number	101/870/085CZ
Medical Device Problem Codes	Deflation Problem (1149); Ventilation Problem in Device Environment (3027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Reason device not evaluated 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 reportable information becomes available.
Event or Problem Description
It was stated that the blue balloon deflated, and the cap came off while the device was used on patient.There was unknown patient involvement.Patient was a male who weights 62 kg.He was not prescribed any medical treatment.The patient was reported to take medications concomitantly via gpe (percutaneous endoscopic gastrostomy).The event was resolved after changing the cannula.There was patient involvement, but no clinical consequences.
Additional Manufacturer Narrative
D1 - brand name, d3, d4 - expiration date and d4 - primary udi number: corrected.H6: updated.H3: one sample was returned for evaluation.Sample was visually and functionally tested and it was found that it was not possible to inflate the cuff because the air does not flow from the balloon pilot into the cuff.The customer reported complaint was able to be confirmed.The root cause of the issue is unknown.A review of the device history records showed there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.There were not any other customer complaints against the reported lot number.

• Brand Name: PORTEX BLUSELECT SUCTIONAID CUFFED TRACHEOSTOMY
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice MN 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20868105
• Report Number: 3011237704-2024-00272
• Device Sequence Number: 8574367
• Product Code: BTO
• UDI-Device Identifier: 15019517076233
• UDI-Public: (01)15019517076233(17)290221(10)4458549
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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: 101/870/085CZ
• Device Lot Number: 4458549
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MEDICATIONS.
• Patient Sex: Male
• Patient Weight: 62 KG