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

Model Number 101/860/080

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3: month and year of event have been provided; 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 Description

It was reported that upon opening during a pre-use check, the product in the package did not have a suction line.There was no patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

D9: 2-jan-2024.H6 - evaluation codes: updated.Device evaluation: one used decontaminated sample was returned for investigation with original label from the blister package.Customer is claiming that there is a missing suction line.The product item received is the product version without a suction line.Unfortunately, without unopened blister we are not able to determine where the mix-up happened (manufacturing or customer).On hand availability of reported lot number was checked by quality manager (completed on 08-jan-2024) and no stock in distribution centers which could be inspected was available.There were no other customer complaints against reported lot number.There is no trend of similar incidents.

• Brand Name: PORTEX TUBES BLUSELECT SUCTIONAID
• Type of Device: 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: 18365827
• MDR Text Key: 331332232
• Report Number: 3011237704-2023-00007
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517077933
• UDI-Public: 15019517077933
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 101/860/080
• Device Catalogue Number: 101/860/080CZ
• Device Lot Number: 4312280
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1