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	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.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
A leak from one of the lumens from a hole in through the lumen distal to the hub.We noticed this problem 2 days after the insertion.
Additional Manufacturer Narrative
The 2.6f vascu picc was returned for evaluation.Visual inspection revealed the extension tubing with the white clamp if filled with blood.Blood can also be seen through the lumen from 1 cm cm to 3.5 cm from the hub.A hole approximately 0.5 cm in length was noted to begin approximately 0.5 cm from the hub.Functional testing was conducted revealing no issues when flushing through the luer with the red clamp.Flushing through the luer with the white clamp was not possible.The lumen was then manually manipulated in an attempt to move the blood out of the lumen.An attempt was then made to flush through the luer with the white clamp again but was not successful.The device was further reviewed by medcomp engineering.Their review revealed the hole in the lumen is on the opposite lumen from the occlusion.The occlusion is determined to be blood that dried in the small lumen during transit and not the cause of the leak.A thorough investigation of product design and manufacturing processes was performed by medcomp engineering in conjunction with the device contract manufacturer.Actions will be implemented to minimize this type of occurrence if determined to be required.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 manufacturing 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.A definitive root cause of the failure could not be determined.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.If resistance is encountered to aspirating or flushing, the lumen may be partially or completely occluded.Warning: do not flush against resistance.Do not use infusion equipment which can exceed the working pressure of 1.0bar max/750mmhg (15.5 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).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: 19246983
• Report Number: 2518902-2024-00033
• Device Sequence Number: 17969416
• Product Code: LJS
• UDI-Device Identifier: 00884908105131
• UDI-Public: 00884908105131
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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?: No
• Operator of Device: Other
• Device Expiration Date: 06/30/2024
• Device Model Number: MR170126024S
• Device Catalogue Number: MR170126024S
• Device Lot Number: MQWX800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2023
• 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 Age: 18 MO
• Patient Sex: Female
• Patient Weight: 7 KG