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

Model Number	ME2064
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: double lumen picc;non-bd used microclave; td (b)(6) 2019.The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.Additional patient information: (b)(6).
Event or Problem Description
It was reported that the tubing set leaked around the filter after a prn medication was administered via the medication line located in the patient's left leg.
Additional Manufacturer Narrative
The customer¿s report that the tubing set filter leaked was confirmed to be from the filter weld line.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.No anomalies were observed anywhere on the set during initial visual inspection.During functional testing the set leaked from the side weld line.Closer inspection of the filter under a lab microscope observed no tool marks or scratches.No further testing could be performed due to the leak.The root cause of the filter weld line leak is due to a supplier manufacturing error.
Event or Problem Description
It was reported that the tubing set leaked around the filter after a prn medication was administered; via the medication line located in the patient's left leg.No additional information is available.

• 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: 8787045
• Report Number: 9616066-2019-01915
• Device Sequence Number: 19332630
• Product Code: FPA
• UDI-Device Identifier: 10885403236280
• UDI-Public: 10885403236280
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 06/18/2019

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 Model Number: ME2064
• Device Catalogue Number: ME2064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 10/31/2019
• 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: 8015,PRI TUBING,8100, TD (B)(6) 2019.
• Patient Age: 9 MO