MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA CIRCUITS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number C45101340-NLJ

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

Udi and pma/510k are unknown; no additional information was provided.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.The sample was received inside a ziploc bag with its closed original packaging.Visual inspection: the sample was visually inspected at a distance of 12 inches under normal lighting; sample was contaminated by a piece of carton and the bag had two holes.The most probable root cause of the issue was deemed to be packaging-related; excess material from the carton box was detached and entered to the bag through the circle perforation.Action(s) taken to mitigate the reported issue(s): as preventive action, the production personnel was notified as awareness of the defect reported by the customer and was re-trained on procedure on how to perform the cleaning and the vacuum of the circuits container to avoid contaminated the units by carton.

Event Description

It was reported that, before opening the package, the customer noticed a brown foreign substance was mixed up in it.No patient injury was reported.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• 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): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15650692
• MDR Text Key: 306002191
• Report Number: 3012307300-2022-25691
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C45101340-NLJ
• Device Lot Number: 3616933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1