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

Model Number	MR170126024S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2023
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
Device was placed under fluoroscopy on (b)(6) 2023.During night shift on (b)(6) 2023 a leak was discovered during flushing.The picc has a hole near the catheter wing in the patient's vein.No harm to patient.
Additional Manufacturer Narrative
The 2.6f picc was returned for evaluation with approximately 15 cm of lumen still attached.Visual inspection revealed a kink in the lumen approximately 0.5cm from the hub.When the device was flushed through the luer with the white clamp no leak was noted.When flushed through the luer with the red clamp a leak was noted at the location of the kink.Under magnification a burst in the lumen can be seen beginning 0.2 cm from the hub.The hole runs along the length of the lumen for approximately 0.5 cm.A definitive root cause cannot be determined.The device subassembly is received from an external supplier and is visually and functionally inspected.Incoming inspection includes visual inspection for kinks, holes, gaps, and functional testing for leaks.At the completion of the final manufacture processes, the catheters are 100% leak tested.Catheter lumens with damage, such as holes, ruptures, tears and/or small pinholes will be detected during this test.Excessive external pressure applied to the lumen may be a contributing cause for this type of failure.The instructions for use (ifu) contains the following warnings and precautions: *small syringes will generate excessive pressure and may damage the catheter.The use of 10cc or larger syringes are recommended.*do not use sharp instruments near the extension lines or catheter lumen.*do not use scissors to remove dressing.*examine catheter lumen and extension(s) before and after each infusion for damage.*do not flush against resistance.*if resistance is encountered to aspirating or flushing, the lumen may be partially or completely occluded.If the lumen will neither aspirate nor flush, and it has been determined that the catheter is occluded with blood, follow institutional declotting procedure.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 W/MST
• 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: 17143229
• Report Number: 2518902-2023-00045
• Device Sequence Number: 11229797
• Product Code: LJS
• UDI-Device Identifier: 00884908105131
• UDI-Public: 00884908105131
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 06/29/2023

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: 06/30/2025
• Device Model Number: MR170126024S
• Device Catalogue Number: MR170126024S
• Device Lot Number: MQNB630
• 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: 06/16/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 06/29/2023
• Date Device Manufactured: 11/25/2022
• 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