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

Model Number	10012213
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
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
The set was received as an unexpected return with a report that the customer tested 3 extension sets, user primed the extension set with tap water when leak was noticed with the cap in place.When the cap was removed during priming there was no leaks noted.The customer confirmed that there was no patient involvement.The event occurred in nicu.
Additional Manufacturer Narrative
The customer¿s report of a leak with the cap in place was confirmed.Visual inspection of the set noted no damage or any anomalies.Functional testing confirmed liquid emerging from between the extension sets¿ male luer¿s spin collar (nut) and the body of the male luers due to exiting liquid filling the caps and then spilling outward and overflowing as liquid continued to flow though the set during priming.After removing the caps, the fluid was unobstructed and the sets re-primed with no leaks or issues observed.Pressure testing resulted in no leaking.With the caps still attached during priming, the fluid was obstructed as it exited from the male luer which resulted in fluid flowing out of the caps and through the gap in between the spin collar and the male luer.However, this fluid overflow is an expected outcome when the cap is attached; there are no leaks or defects with the set.The root cause of the customer¿s report was due to user technique of leaving the caps attached to the male luer while priming.While this technique ensures the sterility of the male luer, it should be expected that continued fluid flow during priming will cause the liquid to overflow from the cap.
Event or Problem Description
The set was received as an unexpected return with a report that the customer tested (3) extension sets, the user primed the extension set with tap water when the leak was noticed with the cap in place.When the cap was removed during priming there was no leaks noted.The customer confirmed that there was no patient involvement.The event occurred in the nicu.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9179736
• Report Number: 9616066-2019-02840
• Device Sequence Number: 16786269
• Product Code: FPA
• UDI-Device Identifier: 10885403233685
• UDI-Public: 10885403233685
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 09/17/2019

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: 11/09/2020
• Device Model Number: 10012213
• Device Catalogue Number: 10012213
• Device Lot Number: 17116703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 12/03/2019
• 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: CAP, THERAPY DATE UNK.