MAUDE Adverse Event Report: CAREFUSION 60-IN MINIBORE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	ME2050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.The event occurred at children's hospital presumed patient to be a child.
Event or Problem Description
It was reported the male-end connector broke off inside the smartside end cap of the extension tubing.Although requested there was no other information provided.
Event or Problem Description
It was reported that the male-end connector broke off inside the smartside end-cap, of the extension tubing.Although requested, there was no additional event details or patient information provided.
Additional Manufacturer Narrative
Concomitant medical products: port; 3m curos; endocarps; micropore tubing.
Additional Manufacturer Narrative
Photo provided by the customer observed that the distal end male luer connector broke off from the male luer and was still intact to the smartsite vial adapter.The root cause of this failure was not identified.
Event or Problem Description
It was reported that the male-end connector broke off inside the smartside end-cap, of the extension tubing.Although requested, there was no additional event details or patient information provided.

• Brand Name: 60-IN MINIBORE EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9304541
• Report Number: 9616066-2019-03176
• Device Sequence Number: 11270175
• Product Code: FPA
• UDI-Device Identifier: 10885403236266
• UDI-Public: 10885403236266
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2019

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?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 11/25/2019; 01/03/2020
• 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: PRI TUBING,MEDEX SYRINGE PUMPS, TD 01/01/2019