MAUDE Adverse Event Report: CAREFUSION ALARIS SYRINGE MODULE SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	10014916
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 500ml baxter bag, ndc (b)(4), lot number y248633, exp jan 19, 5% dextrose; c20022; mz5307; mz1000-07, sec.Tubing, therapy date: (b)(6) 2018.Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
The customer reported that the set was leaking clear fluids onto the floor.It was reported by the rn that the patient was in the restroom at the time the leak was noted , unable to identify the location of the leak or which set primary or secondary was leaking.There was no report of patient harm.
Event or Problem Description
The customer reported leaking from an unspecified location while the patient was in the restroom.Although requested, there were no further details of the event were provided.There was no patient harm.
Additional Manufacturer Narrative
Additional information provided: concomitant medical products.The customer¿s report of leaking was not confirmed.Visual inspection of set identified no damage or anomalies on the set or the components.Functional and pressure testing resulted in no leaking.The root cause was not identified.

• Brand Name: ALARIS SYRINGE MODULE SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8075010
• Report Number: 9616066-2018-02247
• Device Sequence Number: 19262767
• Product Code: FPA
• UDI-Device Identifier: 10885403233920
• UDI-Public: 10885403233920
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• 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): 10/24/2018

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: 10014916
• Device Catalogue Number: 10014916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 02/07/2019
• 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: 10010453; 8110,8015,PRI TUBING,10ML BD SYRINGE, TD (B)(6) 2018