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

Model Number	S1PIC1.9-S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint catheter failed due to break of the catheter body tubing at the overmolded juncture hub.The catheter is reported to have been indwelling for 43 days when it broke during a routine dressing change.Review of the break planes indicate that the catheter broke because it was stretched beyond its tensile strength limit.Dressing materials returned with the catheter are elastic and not recommended for this application.A full complaint report has been sent to the customer.Based on the investigation, it is reasonable to conclude that the cause of failure is not related to the manufacture of the device.No further action will be taken at this time.
Event or Problem Description
Reportedly, as the rn was completing the dressing change, the picc line broke in two.

• Brand Name: 1.9 FR 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: 7343301
• Report Number: 3007697249-2018-01003
• Device Sequence Number: 1542832
• Product Code: LJS
• UDI-Device Identifier: 00858778006041
• UDI-Public: (01)00858778006041(17)190804(10)170562
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/15/2018

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: 08/04/2019
• Device Model Number: S1PIC1.9-S
• Device Lot Number: 170562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 WK
• Patient Weight: 2