MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY VIAL ADAPTER Q-STYLE; SET, I.V. FLUID TRANSFER

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Pt reported a brief worsening of symptoms but has resolved to baseline after increasing her veletri dose (with md approval), and symptoms have improved overall since starting therapy.Pt also reported difficulty drawing up medication with q-style adapters.Reviewed the need to pressurize vials before drawing medication.Pt aware and follows technique taught to her by cnss while utilizing recommendations from md's office.Pt to try a different adapter to see if she has same issue.Pt did not provide lot number.No interruption to therapy or ill-effects reported.Unknown if pt has adapter on hand for return.No other info, dates, or details provided.Product lot number and expiration date were systematically retrieved from the dispensing system.Reported to (b)(6) by pt/caregiver.

• Brand Name: VIAL ADAPTER Q-STYLE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 17623882
• MDR Text Key: 322133336
• Report Number: MW5144946
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• 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: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2023
• Patient Sequence Number: 1
• Treatment: PUMP.; TUBING.; VELETRI.
• Patient Sex: Female