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	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pleural Effusion (2010); Respiratory Insufficiency (4462)
Date of Event	01/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Infusothorax on the left with dislocated picc.Parenteral nutrition leaked into the pleural cavity, respiratory compromise, pleural puncture necessary and respiratory support with cpap.
Additional Manufacturer Narrative
An investigation has been initiated.Currently waiting for additional information about the incident and 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 device involved in the incident was not kept by the clinic therefore no evaluation is possible, and no photographs of the device were provided.The contract manufacturer conducted a review of the manufacture records for the lot number provided.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.Without an evaluation of the device a root cause determination is not possible.A review of the literature indicates that picc line use may be associated with a wide spectrum of complications that includes infiltration, occlusion, thrombosis, misplacement, migration, infection, breakage, and in rare instances pericardial effusion, cardiac tamponade and massive pleural effusion.The instructions for use include the following complications: malposition, migration, perforation of vessel, cardiac tamponade.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: 18739503
• Report Number: 2518902-2024-00016
• Device Sequence Number: 7234273
• 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: 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): 03/04/2024

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?: No
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown