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

Catalog Number C49101320J

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 08/01/2018

Event Type  malfunction  

Event Description

It was reported that immediately upon the use of the product, the product got torn.No patient injury was reported.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Udi is unknown.No product information has been provided to date.510k is unknown.No information has been provided to date.No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.One sample was received without its original packaging inside a ziploc bag.The sample was visually inspected with a 12 inches distance under normal conditions of illumination.During the visual inspection, a tear was found in the tuber.The root cause was unable to be determined, most likely damaged after leaving the manufacturing facility.As a preventive action production personnel was notified by quality engineer as awareness of the defect reported by the customer.

• 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: 15660778
• MDR Text Key: 306600028
• Report Number: 3012307300-2022-26064
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C49101320J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/24/2022
• 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