MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA CIRCUITS; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number C37101329-NLJ

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

Udi in in operator of device is unknown.No information has been provided to date.A product sample was received and is awaiting evaluation and investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that during the pre-use check, an event that was suspected to be a leakage of air from the product was observed.No patient injury reported.

Manufacturer Narrative

Device evaluation: three (3) pictures were attached, during the analysis conducted it could be observed a top view of the circuit product.The sample was visually inspected under normal conditions of illumination to detect any condition that could cause the failure mode reported.The tape that joins bushing with bag present a void, also bag was not assembled to the top of the bushing.Sample was submitted to a leak test inspection.The bag fails the test, thus the failure mode reported is confirmed; the leak is coming from the assembly with the bushing and the tape.Based on analysis the complaint is not confirmed.No other analysis was performed.Root cause is as a result of wrong material handling by not following the assembly method and inspection on procedure.For corrective actions an awareness notification was made to production personnel in order to explain the importance of adherence or following correctly the outlined procedure.The root cause was traced to manufacturing.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• 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: jim vegel ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 15619185
• MDR Text Key: 302861167
• Report Number: 3012307300-2022-24545
• Device Sequence Number: 1
• Product Code: CAI
• 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,Followup
• Report Date: 06/30/2023

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: C37101329-NLJ
• Device Lot Number: 4269436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 10/17/2022
• Supplement Dates Manufacturer Received: 12/22/2022
• Supplement Dates FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1