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	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A follow up report will be submitted when the investigation is complete.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
After blood collection and during 0.9% saline flushing, the device (lumen) fractured/ruptured.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation.A drawing of the catheter was provided indicating the fracture occurred at the lumen to hub extension junction.Without an evaluation of the actual device involved a definitive root cause could not be determined.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.

• 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: 20370672
• Report Number: 2518902-2024-00063
• Device Sequence Number: 6868292
• 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?: No
• 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: 10/04/2024
• 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: 4 YR
• Patient Sex: Male