MAUDE Adverse Event Report: FOOTPRINT MEDICAL INC. DUAL LUMEN 1.9FR POLYURETHANE PIC CATHETER; PICC

Model Number	P2PIC1.9-S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporting facility is unknown.No device was returned.Investigation of manufacturing documents revelas no evidence of manufacturing related issues that could have contributed to the event.
Event or Problem Description
Picc line reported to have broken during a catheter exchange procedure.The broken portion was surgically removed.The catheter had been indwelling for 39 days prior to incident.Reporting facility is not identified.

• Brand Name: DUAL LUMEN 1.9FR POLYURETHANE PIC CATHETER
• Common Device Name: PICC
• Manufacturer (Section D): FOOTPRINT MEDICAL INC.; 12727 cimarron path; san antonio TX 78249 3405
• MDR Report Key: 11140808
• Report Number: 3007697249-2021-00001
• Device Sequence Number: 14011052
• Product Code: LJS
• UDI-Device Identifier: 00858778006102
• UDI-Public: (01)00858778006102(17)220214(10)200215
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/11/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2022
• Device Model Number: P2PIC1.9-S
• Device Lot Number: 200215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 01/08/2021
• 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: 1 MO