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

Model Number	MPX9103
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
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.
Event or Problem Description
It was reported that a extension set tubing separated when attached to the patient at the point of connection between the y-site port and the male luer.It was still inserted into the patient¿s vein.
Additional Manufacturer Narrative
Additional information added; h.6.(device code).Correction; h.6.(patient code).****************************************************** the customer¿s report that the extension set tubing separated was confirmed based on the provided photos.The reported suspect extension set sample was not received for evaluation.An unopened extension set sample was received instead.Visual inspection, pressure testing, and handling of the received sample observed no separation or issue.Visual inspection observed no separation or issue.The sample was visually inspected for kinks, holes/tears in the tubing or damages to the components.No issue was observed.The root cause was not identified.
Event or Problem Description
It was reported that a extension set tubing separated when attached to the patient at the point of connection between the y-site port and the male luer.It was still inserted into the patient¿s vein.Although requested, there has been no impact to patient response or additional event information made available to date.

• Brand Name: MAXPLUS EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9532727
• Report Number: 9616066-2019-03770
• Device Sequence Number: 2641607
• Product Code: FPA
• UDI-Device Identifier: 10885403237294
• UDI-Public: 10885403237294
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/09/2019

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: 10/01/2024
• Device Model Number: MPX9103
• Device Catalogue Number: MPX9103
• Device Lot Number: 19105069
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1