MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 7F X 60CM SINGLE PRO LINE CT; PRO-LINE CT

Model Number	MR28037101
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.Our 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
This device was reported to be leaking, and appeared to have a slit across the lumen near the hub proximal to the insertion site.
Additional Manufacturer Narrative
Visual inspection confirms the complaint.There is a slit approximately 0.1cm long going across the lumen approximately 0.2cm from the hub.The slit appears smooth as if cut and not jagged as if torn.The device was implanted for four years prior to occurrence of the issue.The contract manufacturer conducted a review of the manufacture records for the lot number reported.The device was manufactured and inspected according to specification.The manufacture process includes a 100% leak test at the end of the process.This test would have detected the hole if it was present after the manufacture process.A definitive root cause cannot be determined but is most likely not manufacture related.The instructions for use (ifu) contains the following precautions: do not use sharp instruments near the extension lines or catheter lumen.Do not use scissors to remove dressing.Device was used for treatment, not diagnosis.

• Brand Name: 7F X 60CM SINGLE PRO LINE CT
• Common Device Name: PRO-LINE CT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10983948
• Report Number: 2518902-2020-00062
• Device Sequence Number: 3234528
• Product Code: LJS
• UDI-Device Identifier: 00884908034639
• UDI-Public: 884908034639
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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: 08/11/2018
• Device Model Number: MR28037101
• Device Catalogue Number: MR28037101
• Device Lot Number: MHAQ590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR