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

Model Number	10016072
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the nurse found blood on the patient's bed linens.Upon assessment, it was found that the tubing set had separated from the distal port closest to the patient during use in the adult operating room.At the time, the patient was undergoing a surgical procedure with lactated ringers infusing at an unknown rate, as well as, other medications being given throughout the procedure.The tubing set was opened and removed from the package and placed into use that day.The customer later stated that there were no adverse effects caused to the adult patient from the event.
Additional Manufacturer Narrative
The customer's report that the tubing set leaked and separated from the distal port closest to the patient during use was confirmed.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components visual inspection confirmed that the tubing was completely separated at the engagement between the tubing to the set¿s smartsite inlet port.Closer inspection of the separation under a lab microscope observed that the tubing had insufficient solvent applied at the engagement during manufacturing process.Blood residue was also observed throughout the entire set predominately at where the separation occurred.No other anomalies were observed with the set.Functional testing could not be performed due to the separation at the engagement.A dimensional analysis was performed and the tubing was measured and found to be within specification.The root cause of the separation was identified as a manufacturing issue for insufficient solvent being applied at the engagement of the tubing due to equipment and/or operator error.
Event or Problem Description
It was reported that the rn found blood on the patient's bed linens.Upon assessment, it was found that the tubing set had separated from the distal port closest to the patient during use in the adult operating room.At the time, the patient was undergoing a surgical procedure with lactated ringers infusing at an unknown rate, as well as other medications, being given throughout the procedure.The tubing set was opened and removed from the package and placed into use that day.The customer later confirmed, that there was no harm or adverse effects caused to the adult patient from this event.

• Brand Name: EXTENSION SETS
• Common Device Name: SET,EXTENSION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9274794
• Report Number: 9616066-2019-03079
• Device Sequence Number: 13844188
• Product Code: FPA
• UDI-Device Identifier: 10885403234071
• UDI-Public: 10885403234071
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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: 08/19/2022
• Device Model Number: 10016072
• Device Catalogue Number: 10016072
• Device Lot Number: 19085869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 01/09/2020
• 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, TD (B)(6) 2019
• Patient Age: 25 YR