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

Model Number 5500460

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2023

Event Type  malfunction  

Event 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 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
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; cleveland MS 38732
• MDR Report Key: 17106663
• MDR Text Key: 317065991
• Report Number: MW5118298
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00642621073447
• UDI-Public: (01)00642621073447
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RECOMBINATE
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Hispanic
• Patient Race: White