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	12/06/2018
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
Product received unexpectedly, there was a note attached with the returned product stated; "defective, leaking with an event date (b)(6) 2018.Although several attempts made for event details from product received there was no response from the customer or any indication of patient harm.
Event or Problem Description
Product was received unexpectedly; there was a note attached with the returned product which stated, "defective, leaking" with an event date (b)(6) 2018.Although several attempts were made to obtain event details regarding the product received there was no response from the customer or any indication of patient harm.
Additional Manufacturer Narrative
The customer¿s report of leaking was confirmed.Visual inspection including magnification did not show any gaps at the engagement of the microbore tubing and the outlet port of the set¿s filter, and the tubing remained securely attached following a ¿tug¿ test.No other anomalies were observed.Functional and pressure testing confirmed leaking from the engagement between the microbore tubing and the outlet port of the filter.Dimensional analysis was performed and the microbore tubing measured within specification.The source of the leak was determined to be insufficient solvent applied at the engagement.The root cause of the insufficient solvent is improper assembly due to equipment and/or operator error.

• 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: 8281888
• Report Number: 9616066-2019-00180
• Device Sequence Number: 11260460
• Product Code: FPA
• UDI-Device Identifier: 10885403233920
• UDI-Public: 10885403233920
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2019

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 Model Number: 10014916
• Device Catalogue Number: 10014916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 03/04/2019
• 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: 10ML COVIDIEN MONOJECT SYRINGE, TD (B)(6) 2018