MAUDE Adverse Event Report: CAREFUSION ALARIS® SYRINGE MODULE SET; 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	10/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 8110; 8015; sec tubing; ext tubing; mz1000-07; syringe; therapy date (b)(6) 2018.The customer¿s report of a leak at the filter was confirmed.Initial inspection showed no anomalies.Functional testing resulted in leaking at the engagement between the filter outlet and the tubing.Closer inspection of the engagement under magnification showed no damages or tool marks.Insufficient solvent was observed at the engagement.The tubing measured within specification.The cause of the leak is insufficient solvent application during manufacturing.
Event or Problem Description
The customer reported that at 2246 the mother of the baby reported a leak on the baby's blanket.Upon examination the nurse noted that the filter part of the medication line was leaking.An unspecified medication had been given at 2201, and a flush was infusing when the leak was noted.The nurse stopped the infusion and removed the filter, reattached a new medication line, and reordered new medication from the pharmacy.There was no report of patient harm.The sample received was labeled "tpn running.".

• Brand Name: ALARIS® SYRINGE MODULE SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8039097
• Report Number: 9616066-2018-02105
• Device Sequence Number: 11107538
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2018

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: 10/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1