MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 2.6F X50CM DUAL VASCU-PICC

Model Number	MR17012600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Currently waiting for the return of the device 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
A picc line broke at the hub when moving a patient from their chair to a bed.
Additional Manufacturer Narrative
The vascu picc was returned for evaluation.Visual inspection confirms the complaint as the lumen appears to have torn from the hub.Under magnification it appears the lumen was torn off as the edges appear jagged.The lumen/hub joint appears intact.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test.This test is performed as a last step in the process and would have detected any holes, leaks, or weak spots if they had existed at the time of manufacture.It was reported that the issue occurred as the patient was being moved.The condition of the tear suggests the tear occurred as a result of pull forces being applied that exceed those the device is designed to withstand.Such forces can occur if the tubing becomes caught while moving the patient.A definitive root cause cannot be determined but is not likely manufacture related.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: 2.6F X50CM DUAL VASCU-PICC
• Common Device Name: VASCU-PICC
• 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: 12846662
• Report Number: 2518902-2021-00065
• Device Sequence Number: 4317547
• Product Code: LJS
• UDI-Device Identifier: 00884908093711
• UDI-Public: 884908093711
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 01/13/2022

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: 08/15/2023
• Device Model Number: MR17012600
• Device Catalogue Number: MR17012600
• Device Lot Number: MPFL140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2020
• 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