MAUDE Adverse Event Report: CAREFUSION TEXIUM NEEDLE-FREE SYRINGE 30ML; SYRINGE, PISTON

Model Number MY8030

Device Problems Fluid/Blood Leak (1250); Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

It was reported that a texium syringe had major employee safety and patient safety concerns.First noticed 7 years ago when the texium product was implemented.This residue found occurs at least 90% of the time when using texium to compound hazardous drugs and biologics.All of these documented issues happened in the pharmacy and did not reach the patient.To resolve the issue, visible residue was deactivated and removed from the outside of the closed system drug-transfer device.The pharmacist remade the drug that was visibly cored and used filter set to verify that nothing reached the patient.

Manufacturer Narrative

Cont¿d from section d.11: 240mg vial, lot: abh3865, exp: mar2021, opdivo injection.Additional-updated information: d.1, d.2, d.4, d.10, d.11, g.5, and h.4.The customer¿s report of residue on the texium syringe was not confirmed.The vialshield and texium syringe were visually inspected for cracks, holes/tears or damages to the components.Visual inspection observed no residue with the received texium or smartsite vialshield.Functional testing did not find any leaks or replicate any instances of residue when activating and deactivating the mating components between the texium syringe and smartsite vialshield.The mating male and female luer components were measured and were found to be within iso standards.The root cause of the customer¿s report could not be determined.

Event Description

It was reported that a texium syringe had major employee safety and patient safety concerns.First noticed (7) years ago when the texium product was implemented.The residue found occurs at least 90% of the time when using texium, to compound hazardous drugs and biologics.All of these documented issues happened in the pharmacy and did not reach the patient.To resolve the issue, visible residue was deactivated and removed from the outside of the closed system drug-transfer device.The pharmacist remade the drug that was visibly cored and used filter set to verify that nothing reached the patient.

• Brand Name: TEXIUM NEEDLE-FREE SYRINGE 30ML
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9291568
• MDR Text Key: 181743127
• Report Number: 9616066-2019-03116
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K071108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2022
• Device Model Number: MY8030
• Device Catalogue Number: MY8030
• Device Lot Number: 91901605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRI TUBING, MV0520.