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

Catalog Number C45041345-NLJ

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

Udi is unknown.No information provided to date.Premarket (510k) number is unknown.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).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.The samples were visually inspected at a distance of 12 under normal lighting to received unit, in order to detect any damage on the unit.The breathing bag have a hole.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.A random sample of (b)(4) units was taken from the manufacturing process, in order to perform a visual inspection to verify that all components were free of damage (scuffs, pinch marks, etc.), cracks, crazing, cuts or other workmanship defects that can affect assembly function or appearance.All the inspections and verifications are being performed by the production personnel and verified by the quality inspectors.The root cause of the reported issue was that the production personnel did not detect and scrap the damaged breathing bag.Actions were taken to mitigate the reported issue: a quality alert (qalert) was generated on to ensure that production personnel detect any marks or damage on the breathing bags.Production personnel was trained on the qalert.

Event Description

It was reported that during a pre-use check, the customer noticed air was leaking from the anesthesia circuit or bag.No patient injury was reported.

• Brand Name: PORTEX DISPOSABLE ANESTHESIA BREATHING CIRCUIT
• 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; 2-12-12 kitanagaseomote-machi,; minneapolis, MN 55442
• MDR Report Key: 15656239
• MDR Text Key: 307042568
• Report Number: 3012307300-2022-25886
• 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: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C45041345-NLJ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• 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