MAUDE Adverse Event Report: MEDCOMP 2.6F X 50CM DUAL LUMEN PICC; VASCU-PICC

Model Number	MR17012601
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are currently waiting fro additional information and the return of the sample for evaluation.When the investigation is completed a final report will be submitted.
Event or Problem Description
Catheter developed leaking in one of the lumens.
Additional Manufacturer Narrative
The device involved was not returned for evaluation.Attempts to obtain additional information about the device and event and to have the sample returned for evaluation were unsuccessful.Without sufficient information, or an evaluation of the device involved, we are unable to determine the cause or factors that may have contributed to this event.

• Brand Name: 2.6F X 50CM DUAL LUMEN PICC
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6976672
• Report Number: 2518902-2017-00058
• Device Sequence Number: 1352305
• Product Code: LJS
• UDI-Device Identifier: 00884908085693
• UDI-Public: 884908085693
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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: 03/30/2020
• Device Model Number: MR17012601
• Device Catalogue Number: MR17012601
• Device Lot Number: MJCY330
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/25/2017
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention