MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA CIRCUITS; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE

Catalog Number C37101329-NLJ

Device Problem Leak/Splash (1354)

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

Event Date 03/01/2021

Event Type  malfunction  

Event Description

It was reported that during a pre-use check, leakage of air was observed.No patient injury.No additional information is available for this complaint.

Manufacturer Narrative

Udi number and g5 are unknown.Event problem and evaluation codes: updated.A device history record (dhr) review was conducted which indicated the lot was manufactured with 1,650 pieces and was completed with a sort instruction for bad assembly on the tube to the wye.Issue was identified by the operator on the process, nevertheless, this issue is not related with the failure reported by the customer.Three product samples and photos were received for evaluation.Visual inspection and functional testing found only one of the three samples provided it is confirmed as leakage failure for a hole in the breathing circuit due embedded resin on the rings of the circuit.A non-conforming event (nce) was opened along with an internal ncr (b)(6) 2021 due the occurrence of this failure report, and investigation to identify the root cause will be performed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16691493
• MDR Text Key: 313420342
• Report Number: 3012307300-2023-03655
• 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
• Report Date: 04/06/2023

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 Expiration Date: 09/09/2023
• Device Catalogue Number: C37101329-NLJ
• Device Lot Number: 4051213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Race: Asian