MAUDE Adverse Event Report: ANGIODYNAMICS INC. ANGIODYNAMICS LOW PROFILE PORT WITH VORTEX TECHNOLOGY; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number CT60LPPDV10

Device Problems Contamination (1120); Melted (1385); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Package of port kit intact and sterile, but when opening the kit, one of the stylets had melted plastic, or some kind of debris stuck to it within the sterile packaging.Md was made aware.Kit taken off the sterile field and replaced with a new one and scrub tech changed sterile gloves prior to receiving the new port kit.This port was never implanted into the patient or even touched the patient.Fda safety report id# (b)(4).

• Brand Name: ANGIODYNAMICS LOW PROFILE PORT WITH VORTEX TECHNOLOGY
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS INC.
• MDR Report Key: 15760354
• MDR Text Key: 303415390
• Report Number: MW5113171
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: CT60LPPDV10
• Device Lot Number: 5740797
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1