MAUDE Adverse Event Report: CAREFUSION 16 IN NON-DEHP STANDARD BORE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MX9166
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
Event or Problem Description
It was reported that there was leakage coming from the back side of the filter from the built-in "circle area".It was further confirmed during follow-up, that there was no patient harm as a result of this event.
Event or Problem Description
It was reported that there was leakage coming from the back side of the filter from the built-in "circle area", during a tpn infusion.It was further confirmed during follow-up, that there was no patient harm as a result of this event.
Additional Manufacturer Narrative
The customer¿s report that there was leakage from the back side of the filter from the built-in "circle area" was not confirmed.The set was visually inspected for obvious damage such as cracks, kinks, holes, and tears in the tubing and its components.Moldy residue was observed on the surface of the set¿s packaging.No anomalies or evidence of damage were observed on the filter or the set upon visual inspection.The customer¿s experience was not replicated during functional and pressure testing.No leaks or issues were observed.The root cause could not be determined.

• Brand Name: 16 IN NON-DEHP STANDARD BORE EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9250819
• Report Number: 9616066-2019-03001
• Device Sequence Number: 14041441
• Product Code: FPA
• UDI-Device Identifier: 10885403237652
• UDI-Public: 10885403237652
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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: 01/30/2024
• Device Model Number: MX9166
• Device Catalogue Number: MX9166
• Device Lot Number: 19017181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1