MAUDE Adverse Event Report: CAREFUSION 303, INC. TEXIUM; SYRINGE, PISTON

Model Number	MY8010
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was sedated for lumbar puncture with intrathecal chemotherapy.Lumbar puncture and csf collection completed without problem, attempted to attach it chemo syringe to hub of spinal needle, some flash of yellow methotrexate fluid noted, but once fully attached, could not infuse chemo, plunger would not budge.Removed, readjusted, and re-attached, still would not infuse.Removed again, spinal needle inspected by attending and csf noted to still be freely flowing.Third attempt also unsuccessful.

• Brand Name: TEXIUM
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 16130590
• Report Number: 16130590
• Device Sequence Number: 20713907
• Product Code: FRN
• UDI-Device Identifier: 50885403221673
• UDI-Public: (01)50885403221673
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/01/2022
• Report Date (Section F): 12/01/2022

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 Model Number: MY8010
• Device Catalogue Number: MY8010
• Device Lot Number: (10)92127202
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 28 KG
• Date Report Sent to FDA: 12/01/2022