MAUDE Adverse Event Report: FOOTPRINT MEDICAL INC. SINGLE LUMEN 1.9FR SILICONE PICC PROCEDURAL KIT; PICC, PERCUTANEOUS, PERIPHERALLY INSERTED CENTRAL CATHETER

Model Number	S1PIC1.9-S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for lot #191140 was reviewed.All catheters passed in-process and final inspection criteria including leak testing.Hospital staff claim that they "did not think it was the catheter itself, but damage caused by manipulation of the line and the parent putting strain on it inadvertently".Based on the dhr review and the statement from (b)(6) staff, it is reasonable to conclude that this is not a manufacturer defect.
Event or Problem Description
During assessment of the picc, the dressing appeared wet underneath.Md was notified and placement was verified.The dressing was changed and the picc was noted to be leaking from the picc tubing where the tubing meets the plastic heart.The line was discontinued upon discovery of leak.

• Brand Name: SINGLE LUMEN 1.9FR SILICONE 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: 9413466
• Report Number: 3007697249-2018-11001
• Device Sequence Number: 16289993
• Product Code: LJS
• UDI-Device Identifier: 00858778006041
• UDI-Public: (01)00858778006041(17)210816(10)191140
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K091488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2019

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: 08/16/2021
• Device Model Number: S1PIC1.9-S
• Device Lot Number: 191140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 12/04/2019
• 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