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

Catalog Number C37091718-NL

Device Problem Material Perforation (2205)

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

Event Type  malfunction  

Manufacturer Narrative

(udi) and (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).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.One (1) sample was received without its original packaging.The sample was visually inspected at a distance of 12 inches under normal lighting to received unit, in order to detect any damage on the unit; it was found that there were holes in bag.The most probable root causes are: bag was sent by supplier in defective conditions and production personnel did not detect this issue during the assembly process; or bag was damaged during the manufacturing process.Action(s) taken to mitigate the reported issue(s): as preventive action, production personnel was notified by area trainer as awareness of the defect and to ensure that operators verify that breathing bags are free of holes and damage.

Event Description

It was reported that multiple breathing bags in the custom circuits have small tears or perforations in the non-latex 3l bag.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: 15638648
• MDR Text Key: 306923397
• Report Number: 3012307300-2022-25371
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2021
• Device Catalogue Number: C37091718-NL
• Device Lot Number: 3565034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1