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 Consequences Or Impact To Patient (2199)

Event Date 09/27/2015

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

The customer reported an rn was pushing epirubicin through the y site of a texium primary set with a texium bonded syringe when the drug leaked between the syringe and the primary set at the y site.There was no patient harm reported.

Manufacturer Narrative

The customer¿s report that a texium syringe and iv set leaked was confirmed.The set and syringe were visually inspected for damage such as incomplete bonding engagements, cracks, kinks, holes, and tears.The actuator tabs of the texium adaptors were not damaged.No anomalies or evidence of damage was observed.Functional testing was performed confirmed a drop of liquid leaked from between the distal smartsite and the texium luer of the syringe.Pressure testing was performed; no leakage confirmed.Further testing was performed at (b)(4) facilities in (b)(4).The leak was verified when using the customer¿s syringe and iv set during simulated infusion.However, leaks were not observed when new components were used or when the returned iv set was used with a new texium syringe.The probable cause was attributed to a pressure build-up in the shaft of the texium male luer resulting in a fluid leak path.

Event Description

The customer reported an rn using a texium bonded syringe was pushing epirubicin 40 mg/20 ml through the y-site of a texium primary set when the drug leaked at the connection of the texium bonded syringe to the y-site on the primary set.There was no patient harm reported.

• 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
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 5144908
• MDR Text Key: 28032097
• Report Number: 9616066-2015-01254
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Followup,Followup,Followup
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MY8060
• Device Catalogue Number: MY8060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 59