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	10/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 10ml bd syringe ref (b)(4), lot 812911a, exp (b)(6) 2021, 0.9% nacl injection, therapy date (b)(6) 2018.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 customer reported that during an unspecified infusion, the user noted that the patients bed was wet, upon closer examination the nurse observed that the filter was leaking.There was no report of patient harm.The event occurred in the (b)(6).
Additional Manufacturer Narrative
Patient was an infant.The customer¿s report that the filter was leaking was confirmed.Visual inspection of the set noted no damage or anomalies.Further inspection of the separated tubing end observed there were insufficient to none areas of expected solvent, and the tubing depth did not appear to have been fully inserted within the filter component.Functional testing confirmed leaking from the engagement between the outlet of the filter and microbore tubing.Dimensional analysis of tubing measured to be within specification.The root cause was due to a manufacturing assembly issue of insufficient solvent at the tubing engagement to the filter component.
Event or Problem Description
The customer reported that during an unspecified infusion, the user noted that the patients bed was wet; upon closer examination the nurse observed that the filter was leaking.There was no report of patient harm.The event occurred in the nicu.

• 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: 8072351
• Report Number: 9616066-2018-02198
• Device Sequence Number: 1558085
• 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): 10/19/2018

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: 11/02/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 02/05/2019
• 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: 8110,8015,MZ1000-07,SYR TUBE, TD (B)(6) 2018
• Patient Age: 3 YR