MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 2.6F X 50CM DUAL VASCU-PICC

Model Number	MD17012601
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received and is entering the investigation process.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 avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Bedside nurse reports both lines infusing throughout the day without difficulty.Intermittent alarm to white lumen.Tpa infused to white lumen and allowed to dwell.Unable to withdraw after appropriate dwell time.Pnp to bedside, attempted to clush with 10cc syringe, observed leaking at the site.The line was removed.
Additional Manufacturer Narrative
The 2.6f vascu picc was returned for evaluation.Visual inspection confirms the complaint as a leak was noted in the lumen approximately 1 cm from the hub.When viewed under magnification it can be seen that the lumen has been twisted just above the area of the hole.Magnification confirms the hole is a cut and not a tear/rupture.The device contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation showed the device was manufactured according to specification with no non-conformances or abnormalities.A root cause cannot be determined.We are not able to determine the circumstances that may have led to this event.The report indicated they needed to use tpa (thrombolytic agent) due to intermittent alarms.This would indicate that the line was beginning to clot or was clotted.The instructions for use (ifu) contain the following warning.Do not flush against resistance.Repeated flushing or infusing against resistance may have contributed to the lumen rupture.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.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 X 50CM DUAL VASCU-PICC
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 11350085
• Report Number: 2518902-2021-00011
• Device Sequence Number: 4107157
• Product Code: LJS
• UDI-Device Identifier: 00884908146493
• UDI-Public: 884908146493
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: 08/01/2022
• Device Model Number: MD17012601
• Device Catalogue Number: MD17012601
• Device Lot Number: MPGT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 03/19/2021
• 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: 6 WK
• Patient Weight: 4