MAUDE Adverse Event Report: VYGON CORPORATION PREMICATH 28 G (1 FR) 20 CM CATHETER STYLET SPLITTING NEEDLE; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 1261.203G

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hematoma (1884)

Event Date 07/19/2021

Event Type  Injury  

Event Description

Picc line placed right sided access; noted large hematoma to right neck following start of infusion.The picc line was removed and upon removal there appeared to be a 1mm piece of the guide wire lodged in through the picc line.The guide wire has since fallen out of the picc but both the picc and guide wire were retained for event review.

• Brand Name: PREMICATH 28 G (1 FR) 20 CM CATHETER STYLET SPLITTING NEEDLE
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): VYGON CORPORATION; 2750 morris rd suite a200; lansdale PA 19446
• MDR Report Key: 12287288
• MDR Text Key: 265369815
• Report Number: 12287288
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1261.203G
• Device Catalogue Number: 1261.203G
• Device Lot Number: 20G023D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention