MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, 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
Additional information: an unexpected return confirmed a male luer break.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.The set was visually inspected for cracks, misassemblies or damages to the components.No further testing could be performed due to the broken male luer collar.Device history record for model me2017 could not be performed due to no lot number being provided by customer.The root cause was identified as related to design of the specific male luer component.
Event or Problem Description
Product was received as an unexpected return with an unspecified failure.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10376085
• Report Number: 9616066-2020-02454
• Device Sequence Number: 14188517
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/19/2020

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: 03/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1