MAUDE Adverse Event Report: CAREFUSION MINIBORE TRI-FUSE SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	ME1021
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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.Concomitant disposables: (2) bbraun caresite nfv; bbraun smallbore extension set; pre-filled syringe.
Event or Problem Description
The customer reported a generalized recurring product concern in which the male luer is unable to be disconnected and becomes stuck inside the valve or the female luer of the mating device that it is connected to.The nursing staff have resorted to attempting to remove the tubing set from the patient while using hemostats only to have the male luer break off.The customer further states that they do not use alcohol on the male luer when they connect the sets together.The nurse will prime the set with the fluid that will be delivered and then connect the syringe to the set and prime until the fluid exits at the male luer with the duct cap still attached., this is also done for dextrose as well.Before the nurse connects the male luer to an open female luer, the nurse will use a prefilled syringe to place saline into the female luer before connection to ensure that an air bubble is not introduced.There was no report of patient harm.

• Brand Name: MINIBORE TRI-FUSE SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7997140
• Report Number: 9616066-2018-01979
• Device Sequence Number: 18939587
• Product Code: FPA
• UDI-Device Identifier: 10885403235955
• UDI-Public: 10885403235955
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/26/2018

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: ME1021
• Device Catalogue Number: ME1021
• 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: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1