MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 4F X 13CM PED. DBL. LUMEN; INFUSION CATHETER

Model Number	MC2LP-313S
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Catheter showing failure in the routes when infusing medication through the distal route, it returns through the proximal route.
Additional Manufacturer Narrative
The complained device was returned for evaluation.Visual inspection confirms the complaint as flushing through one luer results in water coming back through the opposite luer.A supplier corrective action request was issued to the contract manufacturer.The contract manufacturer's investigation identified a manufacturing process issue that could affect the likelihood of a cross-lumen leak.The process has been modified to reduce the likelihood of a cross-lumen leak.The device in this complaint was manufactured prior to the change in the process.In addition, the 100% leak test also performed on these devices as a last step in the manufacture process was also updated to provide more precise instructions.The inspection procedure was also updated to reflect the change to the process operation.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.

• Brand Name: 4F X 13CM PED. DBL. LUMEN
• Common Device Name: INFUSION CATHETER
• 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: 15495645
• Report Number: 2518902-2022-00056
• Device Sequence Number: 6068035
• Product Code: LJS
• UDI-Device Identifier: 00884908028331
• UDI-Public: 884908028331
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/04/2024
• Device Model Number: MC2LP-313S
• Device Catalogue Number: MC2LP-313S
• Device Lot Number: MMCG970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown