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

Model Number	MP9002-C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
It was reported that the bd maxplus extension set broke at an unspecified location during apheresis procedure.
Additional Manufacturer Narrative
The customer report that the maxplus extension set broke was confirmed.The customer provided a photo showing a maxzero connector with a bent luer tip.Visual inspection of the as-received sample observed the maxzero connector was separated from the female luer component.The maxzero connector's luer tip was bent and the female luer had some of its material protruding out from the opening.Further inspection under magnification observed markings that indicated use of a hemostat.No functional testing was deemed necessary due to the obvious damage.The maxzero connector's luer tip was bent and the female luer had some of its material protruding out from the opening.The root cause of the customer's report was not identified.
Event or Problem Description
It was reported that the bd maxplus extension set broke at an unspecified location during an "apheresis" procedure.

• Brand Name: EXTENSION SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8820460
• Report Number: 9616066-2019-02041
• Device Sequence Number: 2838471
• Product Code: FPA
• UDI-Device Identifier: 10885403236761
• UDI-Public: 10885403236761
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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 Expiration Date: 11/16/2023
• Device Model Number: MP9002-C
• Device Catalogue Number: MP9002-C
• Device Lot Number: 18116247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1