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

Model Number	MR17012601
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.Additional information and the return of the sample have been requested.When the investigation is complete a final report will be submitted.
Event or Problem Description
The central venous catheter was noted to be occluded and bulging approximately 2 months after insertion.Upon removal, a tear was noted at the 4 cm mark.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation.Attempts to obtain additional information and the sample 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 INFUSION CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6371576
• Report Number: 2518902-2017-00008
• Device Sequence Number: 933006
• Product Code: LJS
• UDI-Device Identifier: 00884908085693
• UDI-Public: 884908085693
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2017

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: 05/23/2019
• Device Model Number: MR17012601
• Device Catalogue Number: MR17012601
• Device Lot Number: MHPG970
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2017
• Supplement Report FDA Received Date: 04/13/2017
• 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
• Patient Weight: 3