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

Model Number	101/860/070
Medical Device Problem Codes	Inflation Problem (1310); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
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, udi, and h4.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 there was a leak from the cuff and the cuff did not inflate.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H3 and h6.Evaluation codes: updated.Device evaluation: one used decontaminated device sample was returned for investigation without its original packaging.Under visual inspection the sample appeared to be in good condition.During functional inflation testing it was found that it is difficult to inflate the cuff, the cuff leaks.Inflated cuff by a syringe filled with air and placed the device under water.An air leak was detected from the pilot balloon and a hole was visible.The complaint was confirmed.Because the failure was observed during use (not prior to use as required by ifu) it is most probable that the failure happened due to poor user handling.A device history record (dhr) review could not be performed as the lot number was unknown.No action was taken, and no trend of similar customer complaints was identified.D4 - partial udi provided.

• 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: 18886287
• Report Number: 3011237704-2024-00057
• Device Sequence Number: 19592565
• Product Code: BTO
• UDI-Device Identifier: 15019517076134
• UDI-Public: (01)15019517076134
• 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): 04/11/2024

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: Other
• Device Model Number: 101/860/070
• Device Catalogue Number: 101/860/070CZ
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/11/2024
• 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