MAUDE Adverse Event Report: UNKNOWN BAXJECT DEVICE; SET, I.V. FLUID TRANSFER

Patient Problems Headache (1880); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

Headache that coincided with discovery of plastic particles in medication after mixing with baxject device.Patient reported that he experienced transient headaches in various locations of his head after discovery of plastic fragments in his reconstituted medication.

• Brand Name: BAXJECT DEVICE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17949708
• MDR Text Key: 325971674
• Report Number: MW5147042
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/11/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2023
• Patient Sequence Number: 1
• Treatment: #1 - NAME AND STRENGTH: RIXUBIS 2601-3900.#1 - MANUFACTURER/COMPOUNDER: TAKEDA.#1 - NDC # OR UNIQUE ID: 00944-3034-02.#1-LOT#: TNA21015AG.
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 115 KG