MAUDE Adverse Event Report: MEDCOMP 6FX60CM TRPL PRO-PICC; PRO-PICC CT

Model Number	MR17036306MB
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Swelling (2091)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Requests for additional information have been made.
Event or Problem Description
There is a rupture in the line approximately 2cm from the hub.

• Brand Name: 6FX60CM TRPL PRO-PICC
• Common Device Name: PRO-PICC CT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7893132
• Report Number: 2518902-2018-00050
• Device Sequence Number: 2725990
• Product Code: LJS
• UDI-Device Identifier: 00884908083378
• UDI-Public: 884908083378
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/20/2018

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: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: MR17036306MB
• Device Catalogue Number: MR17036306MB
• Device Lot Number: MKAP480
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 09/20/2018
• 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