MAUDE Adverse Event Report: CAREFUSION TEXIUM NEEDLE-FREE SYRINGE, 60 ML; SYRINGE, PISTON

Model Number MY8060

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

It was reported that drops of fluorouracil was leaking behind the barrel of the syringe as the pharmacy technician was pushing the medication into the infusion set attached to the cadd device.The pharmacy technician was not harmed.There was no patient involvement as the event occurred while the medication was being prepared in the pharmacy department.

Manufacturer Narrative

The customer's report of leaking behind the barrel of the syringe was not confirmed based on functional testing of the as-received sample.Fluid was pulled/pushed through with no leak or issue.Air was also pulled/pushed through while components were underwater and there was no leak or issue.The root cause was unable to be identified.

Event Description

It was reported that drops of fluorouracil was leaking behind the barrel of the syringe as the pharmacy technician was pushing the medication into the infusion set attached to the cadd device.The pharmacy technician was not harmed.There was no patient involvement as the event occurred while the medication was being prepared in the pharmacy department.

• Brand Name: TEXIUM NEEDLE-FREE SYRINGE, 60 ML
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9662460
• MDR Text Key: 178147322
• Report Number: 9616066-2020-00326
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10885403221699
• UDI-Public: 10885403221699
• Combination Product (y/n): N
• PMA/PMN Number: K071108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

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: Health Professional
• Device Expiration Date: 07/10/2022
• Device Model Number: MY8060
• Device Catalogue Number: MY8060
• Device Lot Number: 91919102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CADD ADMIN SET, CADD PUMP, TD 01/15/2020