MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. VASCU-PICC®

Model Number	MD17012601
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.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 available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Vascu picc was noted to be leaking approximately 1 cm below the suture wing.
Additional Manufacturer Narrative
The 2.6f vascu picc was returned for evaluation.Visual inspection confirms the complaint as a small hole can be seen approximately 1 cm from the hub, then extending lengthwise approximately 0.3 cm down the lumen.Under magnification it can be seen that the lumen around the hole appears stretched, indicative of having ballooned prior to bursting.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 manufacturing 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.Excessive external pressure applied to the lumen may be a contributing cause for this type of failure.The instructions for use (ifu) include warnings and parameters for infusion equipment and bolus injections to avoid excessive pressures.If resistance is encountered to aspirating or flushing, the lumen may be partially or completely occluded.Do not flush against resistance.

• Brand Name: 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: 20383477
• Report Number: 2518902-2024-00067
• Device Sequence Number: 15455755
• Product Code: LJS
• UDI-Device Identifier: 00884908146493
• UDI-Public: 00884908146493
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K102966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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 Model Number: MD17012601
• Device Catalogue Number: MD17012601
• Device Lot Number: MRGP910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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: Female
• Patient Weight: 3 KG