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

Catalog Number KM-203JP

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Phone: (b)(6).

Event Description

Information was received indicating that a smiths medical breathing circuit was found to have a deformation in the connector which made the product unusable.This was found during pre-use check.There was no patient injury nor reported adverse events.

Manufacturer Narrative

Other, other text: additional information: d4, h6 and h10 this remediation mdr was generated under protocol b10010116, as a result of warning letter cms#617147.The opened products were returned and sent to the supplier for evaluation.Visual inspection was performed at 12 inches under normal lighting to received unit, in order to detect any damage on the cuff.Functional test: sample was tested.The deformation of the connector was confirmed.A review of the manufacturing process for the product sample was conducted by quality engineer, to verify that there are no situations or practices that could create the event as described in "description of non-conformance" section.Both products are manufactured with the same manufacturing procedures, process controls and inspections.A random sample of 32 units was taken from the manufacturing process, 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.Production personnel performs a 100-percentage leak test for adult expandable circuits.Quality takes a sample and level inspection per lot, in order to verify is free from damage, tubing corrugations are not crushed or dented.The leak test is performed and level inspection per lot to ensure product does not leak.No nonconformances or issues were noted.The root cause was undetermined.

• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section G): NULL
• MDR Report Key: 12077605
• MDR Text Key: 258735700
• Report Number: 3012307300-2021-06591
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KM-203JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Race: Asian