MAUDE Adverse Event Report: NULL PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Lot Number 3986652

Device Problem Disconnection (1171)

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

Event Date 12/01/2020

Event Type  malfunction  

Event Description

It was reported that immediately after opening the package, the customer noticed one of the device-side connectors was not attached to the product.No patient injury was reported.

Manufacturer Narrative

Two photos and product sample were received for evaluation.Visual and functional testing were performed.In picture 2 it was observed that the sample is missing one (1) bushing connector.The sample was visually inspected at a distance of 12" to 16" under normal conditions of illumination.The sample is missing one (1) bushing connector, failure mode is confirmed.The root cause was determined as procedure not followed.Actions were taken to mitigate the reported issue.Containment awareness notification to production personnel was conducted by the quality engineer on (b)(6)2021 8/mar/2021.Implementation of semi-automatic assembly machine that will replace manual assembly on bushing connectors, assembly machine detects missing bushings before assembling them.D4 udi is unknown.D5 operator of device is unknown.G2 manufacturing site address is unknown.G5 pma/510k is unknown.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section G): NULL
• MDR Report Key: 15411409
• MDR Text Key: 306270466
• Report Number: 3012307300-2022-18963
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/07/2023
• Device Lot Number: 3986652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1