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

Model Number	MPX9103
Medical Device Problem Code	Separation Failure (2547)
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.
Event or Problem Description
It was reported that an 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 in the patient¿s vein.Although requested, there has been no further patient or event information made available to date.
Additional Manufacturer Narrative
Correction; h.6.(patient code).The customer complaint of maxguard extension set tubing broken was confirmed.A photo provided by the customer shows that the non-dhep tubing was separated from the outlet port.Previous investigations have concluded that the root cause of tubing separation issues complaints have concluded to be due to insufficient solvent being applied at the affected engagement due to equipment and/ or operator error.No product will be returned per customer.

• 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: 9531633
• Report Number: 9616066-2019-03764
• Device Sequence Number: 14113811
• 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: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1