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	12/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Rn was preparing device for placement in infant.As rn was removing picc line from clear plastic bag, line broke off from heart shaped disc on catheter.

• 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: 9489368
• Report Number: 9489368
• Device Sequence Number: 11115241
• Product Code: LJS
• UDI-Device Identifier: 00858778006041
• UDI-Public: (01)00858778006041
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/03/2019
• Report Date (Section F): 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: S1PIC1.9-S
• Device Lot Number: 190675
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 DA
• Patient Weight: 3
• Date Report Sent to FDA: 12/03/2019