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

Model Number	ME2050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/20/2019
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.Requested patient demographics however not provided.The event occurred at children's hospital presumed patient to be a infant child or adolescence.Concomitant medical products: port; 3m curos; endocarps; medex syringe pumps; bd syringe.
Event or Problem Description
It was reported that the spin collar shattered.The customer stated; " i have no other information as requested".Although patient impact was requested it was not provided.A note attached to product that stated : "microbore tubing at bedside to be used for intermittent medication administration.Had a curos cap sterile end cover on one end , saline flush on the other end.Nurse went to pull off the curos cap and plastic hub shattered into parts in her hand.Believe to be me2050 carefusion max guard set."event date (b)(6) 2019".
Event or Problem Description
It was reported that the spin collar shattered.The customer stated; " i have no other information as requested".Although patient impact was requested it was not provided.(a note attached to product that stated: "microbore tubing at bedside to be used for intermittent medication administration.Had a curos cap sterile end cover on one end, saline flush on the other end.Nurse went to pull off the curos cap and plastic hub shattered into parts in her hand.Believe to be me2050 carefusion max guard set."event date (b)(6) 2019".).
Additional Manufacturer Narrative
The customer¿s reports that the spin collar shattered was confirmed to be a male luer break.The set was visually inspected for cracks, misassemblies or damages to the components.Visual inspection as received confirmed the male luer collar to be cracked and broken.Closer inspection of the break under a lab microscope observed no stress marks or tool marks.No further testing could be performed due to the broken male luer.The root cause of the break could not be definitively determined.

• Brand Name: EXTENSION SET
• Common Device Name: SET, EXTENSION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9366803
• Report Number: 9616066-2019-03350
• Device Sequence Number: 16800971
• Product Code: FPA
• UDI-Device Identifier: 10885403236266
• UDI-Public: 10885403236266
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2019

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: ME2050
• Device Catalogue Number: ME2050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/23/2019
• Supplement Report FDA Received Date: 02/19/2020
• 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: 2000E, TD (B)(6) 2019; PRIMARY TUBING, TD (B)(6) 2019