MAUDE Adverse Event Report: MEDCOMP 2.6FX50CM DL LMN VASCU-PICC

Model Number	MR17022601
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual examination showed a longitudinal slit at the 2 cm depth mark.We are unable to determine the cause or factors that may have contributed to this event.
Event or Problem Description
Line dressing bloody and on gown.Line removed, break noted around 2 cm mark.

• Brand Name: 2.6FX50CM DL LMN VASCU-PICC
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8843000
• Report Number: 2518902-2019-00044
• Device Sequence Number: 13532800
• Product Code: LJS
• UDI-Device Identifier: 00884908105186
• UDI-Public: 884908105186
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/30/2019

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: 01/25/2022
• Device Model Number: MR17022601
• Device Catalogue Number: MR17022601
• Device Lot Number: MNFC690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 07/30/2019
• 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 Age: 3 YR
• Patient Weight: 15