MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ULTRAPERC SINGLE STAGE DILATOR KIT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/563/080

Device Problems Component Missing (2306); Incomplete or Missing Packaging (2312)

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

Event Date 05/14/2023

Event Type  malfunction  

Manufacturer Narrative

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 the package.It was discovered, that it was missing an accessory.No patient involvement was reported.

Manufacturer Narrative

One device was returned for investigation with open unit pack.Visual inspection confirmed customer complaint of the missing guiding catheter.Root cause determined to be due to a manufacturing process error.Device history review of the reported lot number showed no non-conformities during the manufacturing process.

• Brand Name: PORTEX ULTRAPERC SINGLE STAGE DILATOR KIT
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17221694
• MDR Text Key: 318076422
• Report Number: 3012307300-2023-06830
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/563/080
• Device Lot Number: 4244225
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/21/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male