MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 14F X 24CM SPLIT CATH III

Model Number ASPC24-3E.

Device Problem Improper Flow or Infusion (2954)

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

Event Date 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

We are currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

There was blood reflux in the central lateral pathway.

Manufacturer Narrative

The 14f split cath was returned for evaluation.After decontamination, the distal end of the lumen was clamped.When flushed through the venous luer the solution came back through the arterial side, indicative of a cross lumen leak.A supplier corrective action request was issued to the contract manufacturer.The device was evaluated visually, functionally, and was crossed sectioned.The failure mode of a cross lumen leak was confirmed.A device history record review and a process review were performed.The investigation concluded the failure mode was due to improper assembly rods in the molding process.The failure was not detected during the 100% leak test that is performed at the end of the manufacturing process due to operator error.The machine used for the leak test has an alarm sound for when a failure occurs.This alarm was not activated.Actions taken include retraining of personnel on the hub molding procedure and updating the leak test procedure to include "active alarm verification".Device was used for treatment, not diagnosis.

• Brand Name: 14F X 24CM SPLIT CATH III
• Type of Device: SPLIT CATH III
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 18436070
• MDR Text Key: 331985326
• Report Number: 2518902-2024-00002
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ASPC24-3E.
• Device Catalogue Number: ASPC24-3E.
• Device Lot Number: MQWP470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention