MAUDE Adverse Event Report: CAREFUSION EXTENSION SET; SET,ADMINISTRATION,INTRAVASCULAR

Model Number	10015817
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.Although requested, no additional patient demographics were provided.
Event or Problem Description
It was reported that there was a tubing break and leak.During use, one of the extensions from the quadfuse extension set broke near the hub.It was noted that after the clinician unclamped the quadfuse tubing to administer medication; blood leaked onto the bed.It was observed that the quadfuse tubing was broken and the line was immediately clamped.It was reported that the other three tubing lines of the quadfuse were still in use.No medical or surgical intervention, nor a change in treatment for the patient was required as a result of the event.The patient was a child.Although requested, no additional patient information was provided.
Event or Problem Description
It was reported that there was a tubing break and leak.During use, one of the extensions from the quadfuse extension set broke near the hub.It was noted that after the clinician unclamped the quadfuse tubing to administer medication; blood leaked onto the bed.It was observed that the quadfuse tubing was broken and the line was immediately clamped.It was reported that the other three tubing lines of the quadfuse were still in use.No medical or surgical intervention, nor a change in treatment for the patient was required as a result of the event.The patient was a child.Although requested, no additional patient information was provided.
Additional Manufacturer Narrative
The customer¿s report that the tubing broke and leaked was confirmed.Visual inspection found a lateral crack in the female luer wall of model 10015817 located at the top end of the female luer opposite of the luer gate.Slight cosmetic damages were observed at the center of the female luer.Functional testing was performed by attaching a 10ml lab syringe filled with blue dye water to female luer with the observed crack.The syringe plunger was gently depressed and small droplets were leaking at the connection between the syringe and female luer, confirming the customer¿s report of leakage.The root cause of the female luer crack was identified to be a result of internal stresses created during the manufacturing process that make it more susceptible to chemical/mechanical attacks and the pvc materials used in the new female luer.

• Brand Name: EXTENSION SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9989389
• Report Number: 9616066-2020-01425
• Device Sequence Number: 17102959
• Product Code: FPA
• UDI-Device Identifier: 10885403234057
• UDI-Public: 10885403234057
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: 10015817
• Device Catalogue Number: 10015817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8015,PRI TUBING,8100, TD (B)(6) 2019