MAUDE Adverse Event Report: VYGON USA 90" IV SET WITH 0.22 MICRON FILTER & LOWER Y SITE; FILTERED INFUSION TUBE SET, FPB

Catalog Number T090-022V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burning Sensation (2146)

Event Date 08/05/2014

Event Type  Injury  

Event Description

While a patient was receiving paclitaxel intravenously, they felt a flushing sensation within 10 minutes.The infusion was stopped and 40 mg of solumedrol was administered intravenously.After the intervention, the patient was stable and discharged.There was a delay of 30 minutes.

Manufacturer Narrative

The original reporter stated there were two lots in question.The facility observed patient reactions while using walkmed infusion's products, but they could not definitively state which lots were associated with which patient reactions.The two lots in question are lot 1404065 and lot 1403061.Walkmed infusion received 5 samples from each lot and requested the manufacturer perform a bacterial endotoxin test.The test results were negative for both lots.

• Brand Name: 90" IV SET WITH 0.22 MICRON FILTER & LOWER Y SITE
• Type of Device: FILTERED INFUSION TUBE SET, FPB
• Manufacturer (Section D): VYGON USA; 87 venture dr; dover NH 03820
• Manufacturer (Section G): VYGON USA; 87 venture dr; dover NH 03820
• Manufacturer Contact: edward griffith ; 87 venture dr; dover, NH 03820 ; 2153902002
• MDR Report Key: 4193774
• MDR Text Key: 4983487
• Report Number: 1723533-2014-00018
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: T090-022V
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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