MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX

Model Number 101/860/075CZ

Device Problem Separation Problem (4043)

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

Event Date 11/01/2021

Event Type  malfunction  

Event Description

It was reported that when the customer was using the product with an automatic non-smiths' cuff pressure controller connected, the pilot balloon vigorously detached from the product.No patient injury.

Manufacturer Narrative

H10: device evaluation: the device was returned for investigation.The sample was test using a cuff inflation unit model (cfinf-4-3-002) as pwi-10008350-110 rev.100 indicate, to replicate failure mode reported machine was regulated at maximum pressure allow per procedure (39 mbar = 38.25 cm/h20) and both pressures tested by customer (24.5 mbar = 25 cm /h2o and 19.6 mbar = 20 cm/h20).No discrepancies were detected the sample was fully connected and inflated with all pressures without it disconnected from the equipment.No root cause could be determined since the complaint was not confirmed due the sample was tested and successfully passed.A dhr review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.

• Brand Name: PORTEX
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: david halverson ; 6000 nathan lane north; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 13049056
• MDR Text Key: 282561928
• Report Number: 3012307300-2021-13054
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076141
• UDI-Public: 15019517076141
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/860/075CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1