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

Model Number	MR17012601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Picc leaking at site, removed, found to have a bleb ~ 1cm from hub and crack ~ 2 cm from hub.21g lumen affected, 23g lumen seems fine.Line inserted oct 24, never used for blood draws and no reported issues with high pressures/flushing line.
Additional Manufacturer Narrative
The 2.6f vascu picc was returned with a partially filled syringe attached to the end caps.The syringe and end caps were removed.The device hub is stained brown from approximately 0.5cm above the distal tip extending down approximately 1 cm of the lumen.The device was flushed, and a leak in the lumen was noted approximately 3 cm from the hub.Under magnification the lumen appears to have slightly ballooned around the 1.5 cm mark down to the 3 cm leak.A great deal of dried blood was noted just distal to the leak, suggesting the balloon and leak may have been caused by flushing against resistance.The device 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 performed as a last step in the process.This test would have detected any leaks, holes, or weak spots if it had existed at the time of manufacture.The instructions for use (ifu) contains the following warnings and precautions: * do not use infusion equipment which can exceed the working pressure of 1.0bar max/750mmhg (14.5 psi).*only use infusion equipment complying with standards, which do not exceed a shut-off pressure of 1.0bar.*bolus injections should be slow and must not exceed the maximum bolus pressure of 1.2bar/900mmhg (17.4 psi).*small syringes will generate excessive pressure and may damage the catheter.The use of 10cc or larger syringes are recommended.*do not flush against resistance.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 LUMEN 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: 15926141
• Report Number: 2518902-2022-00070
• Device Sequence Number: 17449436
• Product Code: LJS
• UDI-Device Identifier: 00884908085693
• UDI-Public: 884908085693
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 01/17/2023

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: 03/01/2025
• Device Model Number: MR17012601
• Device Catalogue Number: MR17012601
• Device Lot Number: MQHZ040 S2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• 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