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

Model Number P2PIC1.9-S

Device Problem Use of Device Problem (1670)

Patient Problem Pleural Effusion (2010)

Event Date 02/05/2018

Event Type  Injury  

Manufacturer Narrative

The product and circumstances have been investigated and it is clear by the events that a non-central placement of the catheter was related to this incident.Pleural effusion is a known complication with picc lines; however, non-central placement is one of the factors that increases the chances of pleural effusion.The returned catheter has been investigated and has been determined to be fully functional and without anomaly.The catheter tip and catheter body have been inspected under magnification and show no increased risk of causing plural effusion.It is reasonable to conclude that the effusion was not a result of the product and more likely a result of non-central placement and other possible non-product related circumstances that can lead to chemical erosion.

Event Description

Dual lumen picc was placed on (b)(6) 2018.On (b)(6) 2018, swelling was noted in the infant's neck, chest, and back.A chest x-ray showed that the picc was less central than on previous x-rays.

• Brand Name: DUAL LUMEN 1.9 FR POLYURETHANE PICC PROCEDURAL KIT
• Type of Device: PICC, PERCUTANEOUS, PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): FOOTPRINT MEDICAL, INC.; 12727 cimarron path; san antonio TX 78249 3405
• Manufacturer Contact: robert davis ; 12727 cimarron path; san antonio, TX 78249-3405 ; 2102262600
• MDR Report Key: 7399221
• MDR Text Key: 104449246
• Report Number: 3007697249-2018-02003
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: P2PIC1.9-S
• Device Lot Number: 16256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA