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

Model Number	P1PIC1.4-S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint catheter broke due to excessive force experienced by the tubing at the molded juncture hub.The hospital has stated that they believe the event is "not a result of a defective catheter." there is no injury to the patient and there was no need for medical intervention beyond the extraction of the catheter through normal means.Originally the lot number was reported as #170064, however the hospital confirmed the correct lot number of #170230.Quality and manufacturing review of lot #170230 indicates product was manufactured in accordance with approved quality and manufacturing documentation.There are currently no other complaints on file from lot #170230.After review of the complaint catheter and communication with the facility, it is reasonable to conclude that the product failure is not due to manufacturer defect.A report of the findings has been sent to the customer.
Event or Problem Description
The 1.4 fr polyurethane pic catheter broke at the securement hub during attempted explant.The picc was in place for approximately five days before the adverse event.There was no harm to the infant.

• Brand Name: 1.4 FR POLYURETHANE PIC CATHETER 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: 6811791
• Report Number: 3007697249-2017-07003
• Device Sequence Number: 1760490
• Product Code: LJS
• UDI-Device Identifier: 00858778006072
• UDI-Public: (01)00858778006072(17)190324(10)170230
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K-130507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2017

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: 03/24/2019
• Device Model Number: P1PIC1.4-S
• Device Lot Number: 170230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 DA