MAUDE Adverse Event Report: FOOTPRINT MEDICAL INC. SINGLE LUMEN 1.4FR POLYURETHANE PICC PROCEDURAL KIT; PICC, PERCUTANEOUS, PERIPHERALLY INSERTED CENTRAL CATHETER

Model Number	P1PIC1.4-S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the complaint product indicates that the catheter tubing was sharply kinked which most likely led to premature failure of the device.It is reasonable to conclude that the failure is not related to manufacturing.A full report has been sent to the customer.
Event or Problem Description
The primary rn noticed moisture under the picc line dressing.The catheter was discovered to be leaking approximately 2cm distal of the skin reference mark.There was no harm to the infant.

• Brand Name: SINGLE LUMEN 1.4FR POLYURETHANE PICC PROCEDURAL KIT
• Common Device Name: PICC, PERCUTANEOUS, PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): FOOTPRINT MEDICAL INC.; 12727 cimarron path; san antonio TX 78249 3405
• MDR Report Key: 7832128
• Report Number: 3007697249-2018-07001
• Device Sequence Number: 1229243
• Product Code: LJS
• UDI-Device Identifier: 00858778006072
• UDI-Public: (01)00858778006072(17)200328(10)180275
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K130507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2018

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 Expiration Date: 03/28/2020
• Device Model Number: P1PIC1.4-S
• Device Lot Number: 180275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 12 DA