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

Model Number	ME2017
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: non-bd needle-free connector.Although requested, additional information was not provided.An unspecified failure was reported.The set was inspected for kinks, holes/tears in the tubing, and damages to the components.Visual inspection of the set noted a piece of the male luer collar was broken off.A crack was also observed around the collar.Further inspection observed no stress or tool markings at the break site.No other anomalies was observed.Functional testing resulted in no leaking.It was observed that the set's male luer was broken.The root cause was identified as design of the male luer component.The device history record for model me2017 could not be performed due to no lot number being provided.
Event or Problem Description
An unknown failure was reported.Although requested, additional information was not provided.

• Brand Name: 60 IN ULTRA 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: 10328470
• Report Number: 9616066-2020-02312
• Device Sequence Number: 14014735
• Product Code: FPA
• UDI-Device Identifier: 10885403236242
• UDI-Public: 10885403236242
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/04/2020

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: ME2017
• Device Catalogue Number: ME2017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1