MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 4FX60CM DBL LMN V-P BASIC KIT; VASCU-PICC

Model Number	MR17014201
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.Currently waiting for the sample to be returned for evaluation.
Event or Problem Description
Hospital reports the 4f picc was noted to be fractured and leaking at the base of the white lumen.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation (lost in transit).No photos were provided.Attempts to obtain additional information about the device and event and to have the sample returned for evaluation were unsuccessful.A review of the manufacturing records was not possible as the lot number was not provided.The device was implanted for 3 months prior to the incident.The report indicated the "line believed to be a medcomp 4fr dl vascu-picc".Without sufficient information and an evaluation of the device we are unable confirm a medcomp device was involved or to determine the exact cause of the reported failure.

• Brand Name: 4FX60CM DBL LMN V-P BASIC KIT
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9687437
• Report Number: 2518902-2020-00004
• Device Sequence Number: 19746456
• Product Code: LJS
• UDI-Device Identifier: 00884908032789
• UDI-Public: 884908032789
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121094
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

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 Model Number: MR17014201
• Device Catalogue Number: MR17014201
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 03/18/2020
• 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