MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXJECT II; SET, I.V. FLUID TRANSFER

Model Number	5500460
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patients with hereditary factor viii deficiency receiving recombinate [antihemophilic factor (recombinant)] (ndc: 00944-2845-10, lot: tra22806aa, iu: 2080) reporting plastic particles in the baxject ii device.After reconstitution, shards of plastic are also found within the injection syringe/reconstituted solution which is administered intravenously.It only seems to be appearing in this specific lot number and it is sporadic.Two patients have reported this to us so far.Manufacture has been notified.Reference report: mw5118299.
Event or Problem Description
Additional information received from reporter on 01-nov-2023, for mw5118298.Patient contacted an employee of (b)(6) pharmacy, inc.And sent photos of the medication syringe which contained shards of plastic in the medication solution.This was already reported and resulted in a voluntary recall of the baxject ii device.This was reported after the voluntary recall on 08/28/2023.

• Brand Name: BAXJECT II
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; cleveland MS 38732
• MDR Report Key: 17106663
• Report Number: MW5118298
• Device Sequence Number: 15115918
• Product Code: LHI
• UDI-Device Identifier: 00642621073447
• UDI-Public: (01)00642621073447
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 5500460
• Device Lot Number: (10)GR351003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 11/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RECOMBINATE
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Hispanic
• Patient Race: White