MAUDE Adverse Event Report: FOOTPRINT MEDICAL INC. POLYURETHANE, SINGLE LUMEN 1.9FR (Ø 0.65 MM) X 30 CM LENGTH; PICC

Model Number	P1PIC1.9-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pleural Effusion (2010)
Date of Event	09/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one day after placement of the picc line, the patient needed more oxygen and experienced swelling of the neck.Xray of the patient indicated the catheter was malpositioned.Pleural effusion was reported and the line was removed.The patient symptoms reportedly resolved within one day of picc removal.
Additional Manufacturer Narrative
Investigation included reviewing device history records, information from the user facility, and the returned device.The investigation indicated no evidence of manufacturing related issues that could have contributed to the event.

• Brand Name: POLYURETHANE, SINGLE LUMEN 1.9FR (Ø 0.65 MM) X 30 CM LENGTH
• Common Device Name: PICC
• Manufacturer (Section D): FOOTPRINT MEDICAL INC.; 5823 sebastian place; san antonio TX 78249
• Manufacturer (Section G): FOOTPRINT MEDICAL INC.; 5823 sebastian place; san antonio TX 78249
• Manufacturer Contact: robert davis ; 5823 sebastian place; san antonio, TX 78249 ; 2102262600
• MDR Report Key: 15631967
• Report Number: 3007697249-2022-00004
• Device Sequence Number: 15446268
• Product Code: LJS
• UDI-Device Identifier: 00858778006065
• UDI-Public: (01)00858778006065(17)240520(10)220721
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K130507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2022

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: 05/20/2024
• Device Model Number: P1PIC1.9-S
• Device Lot Number: 220721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 1 DA
• Patient Sex: Unknown