MAUDE Adverse Event Report: FOOTPRINT MEDICAL, INC.; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	S1PIC1.9-S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Rn was attempting to complete picc line dressing change.As rn was completing the dressing change, the line broke in two.Rn was able to remove the line in its entirety.The line was secured per the manufacturer's direction in their instructions for use.The device has been retained and we will return it to the manufacturer when they contact us.

• Brand Name: NA
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): FOOTPRINT MEDICAL, INC.; 12727 cimarron path; san antonio TX 78249
• MDR Report Key: 7218422
• Report Number: 7218422
• Device Sequence Number: 18871418
• Product Code: LJS
• UDI-Device Identifier: 00858778006041
• UDI-Public: (01)00858778006041
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2018
• Report Date (Section F): 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Expiration Date: 08/04/2019
• Device Model Number: S1PIC1.9-S
• Device Catalogue Number: S1PIC1.9-S
• Device Lot Number: 170562
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALARIS IV PUMP
• Patient Weight: 5
• Date Report Sent to FDA: 01/16/2018