MAUDE Adverse Event Report: CAREFUSION TEXIUM NEEDLE-FREE SYRINGE, 3 ML; INTRAVASCULAR ADMINISTRATION SET

Model Number	MY8003
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint of leakage could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model or lot number was not provided by the customer.Root cause analysis: due to no sample being received, an investigation could not be performed and a root cause could not be determined.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that texium needle-free syringe, 3 ml leaked during injection.The following information was provided by the initial reporter: material no: my8003-0006 batch no (lot no): unknown.It was reported the texium syringe leaked while giving an injection.I have one nurse who is having a problem with the 3cc texium syringe leaking every time she injects a s.C.Dose of velcade.All my nurses in the clinic have a problem with the drug wanting to shoot straight out of the needle when they attach the needle to the texium for injection; however they have found a workaround for that issue so i don¿t believe i need help with that.They are holding onto the plunger and pulling back at the same time they attach the needle and therefore preventing the drug from squirting out the needle top.So problem solved on that issue.I don¿t seem to have any leaks at the texium/needle site with any other nurse except one ¿ and she continues to have leaks day after day.I do not have product to return to you nor do i have the exact lot number.As i stated previously; we are using the carefusion syringe with a 25g s.C.Safety needle by covidien for injection of velcade.I was mostly looking for some technique tips or problem solving question/answers for this situation.When the nurse attaches the needle; the velcade leaks from the needle connection every time.Not every nurse in my hem/oncology clinic is having this problem.It is isolated to one nurse and i feel she would benefit from a company personnel or professional to pin point the problem as she wants to create an incident report from it; in fact she has made her supervisor aware and may have written up a jspr already.

• Brand Name: TEXIUM NEEDLE-FREE SYRINGE, 3 ML
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10361436
• Report Number: 9616066-2020-02352
• Device Sequence Number: 16860289
• Product Code: FPA
• UDI-Device Identifier: 10885403221651
• UDI-Public: 10885403221651
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K071108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: MY8003
• Device Catalogue Number: MY8003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other