MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. CVC CATHETER; LT SILICONE CVC

Model Number	MR28010721
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Slow flow in both ways and no reflux in the red way and when performing the "flushing" procedure with saline solution when deactivating it, a fracture occurred.
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.
Additional Manufacturer Narrative
Received one 7f double lumen long-term silicone cvc for evaluation.A visual examination of the device indicated a tear in the lumen approximately 1cm distal to the end of the blue sleeve.The tear is curved, not straight and is approximately 4mm in length.A functional evaluation indicated that the lumen leaks when both the red and blue sides are flushed.The device was evaluated by medcomp engineering.Their review indicates the location, shape, and edges of the tear suggests it may have been caused by an accidental nick to the lumen with a sharp instrument.The contract manufacturer conducted a review of the manufacturing records for the lot number provided.The device history record review established the device was manufactured within specification and customer requirements.There were no deviations or process changes in the manufacturing and/or materials for this part number.All inspections and sequence of operations were properly followed and documented.A 100% leak test is performed during inspection of this device.This test is capable of detecting lumen holes/tears in the lumen that could lead to a malfunction.We are unable to determine the root cause or factors that may have contributed to this event.The report indicated that there was either slow or no flow from either lumen, indicating possible obstruction.The "fracture" occurred during flushing.It appears the catheter may have been stressed beyond the design capabilities.The instructions for use include the following information."excessive force should not be used to flush an obstructed lumen.".

• Brand Name: CVC CATHETER
• Common Device Name: LT SILICONE CVC
• 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: 20370653
• Report Number: 2518902-2024-00062
• Device Sequence Number: 19805729
• Product Code: LJS
• UDI-Device Identifier: 00884908084283
• UDI-Public: 00884908084283
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K003110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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?: No
• Operator of Device: Other
• Device Model Number: MR28010721
• Device Catalogue Number: MR28010721
• Device Lot Number: MRAL620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2023
• 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 Age: 5 YR
• Patient Sex: Male