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

Model Number	MPX5302-C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s report that blood leaked from the extension tubing set while in use could not be determined.Visual inspection of the customer-provided photos showed one new model mpx5302-c in its original packaging with customer indicators pointing to probable leak locations.The second photo showed one new model mp1000-c in its original packaging.The root cause of this failure was not identified as no product was returned and the customer provided photos were of different models.Patient demographics requested but not provided, however the customer stated that the patient was an adult patient.
Event or Problem Description
It was reported that blood leaked from the extension tubing set while in use on an adult patient.There were no adverse effects caused to the patient from the event.
Event or Problem Description
It was reported that blood leaked from the extension tubing set while in use on an adult patient.Although it was noted that there was a delay in treatment, it was also confirmed during follow up, that there was no patient harm or impact as a result of this event.
Additional Manufacturer Narrative
The customer¿s report that blood leaked from the extension tubing set while in use could not be determined.The reported set model mpx5302-c lot unknown was not received for evaluation.The root cause of this failure was not identified as no product was returned.

• 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: 9877190
• Report Number: 9616066-2020-01052
• Device Sequence Number: 3041100
• Product Code: FPA
• UDI-Device Identifier: 10885403237232
• UDI-Public: 10885403237232
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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: MPX5302-C
• Device Catalogue Number: MPX5302-C
• 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: 03/25/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRI TUBING, MP1000-C, TD (B)(6) 2020.