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

Model Number	MR170126024S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.Device is import for export only, not sold in the us.Udi not applicable.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
Patient's bed is wet, nurse looks for the trigger.It becomes apparent that the peripheral cvc is torn apart.Child was asleep, there was no manipulation of the catheter.
Additional Manufacturer Narrative
The 2.6f vascu picc was returned for evaluation with less than 1 cm of the lumen attached.The remainder of the lumen was not returned.Under magnification the distal end of the lumen appears to be cut.It cannot be determined if this is where the reported leak occurred or if it was cut for some other reason.Without the portion of the lumen that contains the leak the complaint cannot be confirmed and a root cause cannot be determined.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 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.A root cause cannot be determined but is not likely manufacture related.

• 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: 20819374
• Report Number: 2518902-2024-00083
• Device Sequence Number: 15664370
• 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: 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): 12/31/2024

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: 04/30/2026
• Device Model Number: MR170126024S
• Device Catalogue Number: MR170126024S
• Device Lot Number: MRAD280
• 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: 11/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 12/31/2024
• Date Device Manufactured: 01/25/2024
• 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: Unknown