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 12/24/2020

Event Type  malfunction  

Manufacturer Narrative

Summary of investigation: actual device was available for investigation.One (1) sample was returned for evaluation p/n 101/860/075cz; the sample was received in used conditions without its original package.The returned sample was visually inspected at 12? to 16? and normal conditions of illumination.Inflation line was detached from pilot balloon was found; the complaint was confirmed.Customer reported: ?three (3) days after starting to use the product, the customer noticed the pilot balloon got detached from the product?.Based on the analysis conducted in the sample provided, inflation line detached failure mode was confirmed.Therefore, according to on pfmea (rmp 1065) the occurrence of this failure condition could be caused by: method not followed (not enough solvent at joint).The lot number provided by the customer was of a component piece and not the product itself so we completed a dhr of each lot where that component was used and no issues were found.A dhr was conducted which indicated all inspections were completed and no issues were noted during manufacture.

Event Description

It was reported that three (3) days after starting to use the product, the customer noticed the pilot balloon got detached from the product.No patient injury was reported.

• Brand Name: PORTEX
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: david halverson ; 6000 nathan lane north; sapporo city, hokkaido; minneapolis, MN 55442
• MDR Report Key: 13115124
• MDR Text Key: 283096853
• Report Number: 3012307300-2021-13494
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076141
• UDI-Public: 15019517076141
• 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
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 101/860/075CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1