MAUDE Adverse Event Report: FOOTPRINT MEDICAL, INC. 1.9 FR POLYURETHANE PIC CATHETER KIT; PICC, PERCUTANEOUS, PERIPHERALLY INSERTED CENTRAL CATHETER

Model Number	P1PIC1.9-S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact cause of failure could not be conclusively determined based on the evaluation of the returned catheter.A review of the device history record for lot #16970 reveal that the catheter was manufactured per documented instructions and no unusual activity was recorded.The complaint catheter evidenced a small tear along the circumference of the tubing.The tear occurred on the catheter tubing near the securement platform.A large amount of adhesive residue can be observed on the catheter near the tear.As suggested by the excessive residue, an improper securement method can allow too much stress on the catheter and predispose the catheter to tears.All pic catheters manufactured at footprint medical inc.Are pressure tested prior to packaging.This catheter was not leaking at the time of packaging and presumably insertion.It is reasonable to conclude that this catheter failure is not the result of manufacture.
Event or Problem Description
A leak was discovered in the picc catheter during a picc dressing change.There was a small hole in the catheter in the external portion near the hub.The physician was notified and the picc was discontinued.

• Brand Name: 1.9 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: 7184188
• Report Number: 3007697249-2017-12002
• Device Sequence Number: 10793832
• Product Code: LJS
• UDI-Device Identifier: 00858778006089
• UDI-Public: (01)00858778006089(17)181216(10)16970
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K-130507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2018

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: 12/16/2018
• Device Model Number: P1PIC1.9-S
• Device Lot Number: 16970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 01/11/2018
• 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