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

Model Number	MRVSP26001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A leak was noted at the junction of the red extension and the catheter hub.
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.
Additional Manufacturer Narrative
The 2.6f vascu picc was returned for evaluation.Visual inspection revealed the distal half of the hub is severely discolored.The side with the red clamp would not aspirate or flush.Attempting to flush this side revealed a leak at the extension-luer junction.A.018" guidewire was taken from stock and inserted into the luer with the red clamp but would only advance 11 cm before stopping.The luer with the white clamp was flushed and aspirated with no issues.Under magnification the extension tubing with the red clamp pulls away from the luer if slight pressure is exerted on the tubing to one side.A supplier investigation request was issued to the contract manufacturer.The contract manufacturer's investigation revealed the device was manufactured according to specification with no non-conformances or abnormalities.Relevant measurements were taken of the returned device, and it was found that all dimensions were within specification.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.The device was implanted more than 2 weeks prior to the event.An implanted catheter is exposed to many variables for which the manufacturer has no influence or control.These variables include but are not limited to patient physiology, care and maintenance of the catheter by healthcare providers, exposure to site care agents and ointments, locking solutions, and off label uses such as power injection.The longer the catheter is implanted and functioning properly the less likely catheter failure can be contributed to a manufacturing defect.We are unable to determine the cause or factors that may have contributed to this event.

• Brand Name: 2.6F X 50CM DUAL VASCU-PICC TLS
• 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: 16689098
• Report Number: 2518902-2023-00031
• Device Sequence Number: 7454877
• Product Code: LJS
• UDI-Device Identifier: 00884908163391
• UDI-Public: 00884908163391
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K120981
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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: 06/30/2024
• Device Model Number: MRVSP26001
• Device Catalogue Number: MRVSP26001
• Device Lot Number: MMJQ290
• 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: 04/03/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 6 MO
• Patient Sex: Male
• Patient Weight: 9 KG