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

Catalog Number T090-022V

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Dyspnea (1816)

Event Date 07/29/2014

Event Type  Injury  

Event Description

While a pt was receiving docetaxel intravenously, they felt the following symptoms within 10 minutes: dyspnea, flushing, and abdominal pain.The infusion was stopped and 4 liters of oxygen was administered.Additionally, 40 mg of solumedrol and 1 mg of ativan was administered intravenously.After the intervention, the pt 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 pt reactions while using walkmed infusion's products, but they could not definitively state which lots were associated with which pt reactions.The two lots in question are lot 1404065 and lot 1403061.Walkmed infusion received 5 samples from each lot and requested the mfr perform a bacterial endotoxin test.The test results were negative for both lots.

• Brand Name: 90" IV SET WITH 0.22 MICRON FILTER AND LOWER Y SITE
• Type of Device: FILTERED INFUSION TUBE SET
• 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: 4202157
• MDR Text Key: 18037853
• Report Number: 1723533-2014-00016
• 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
• 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