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

Model Number	10800173
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s report that the tubing had a hole was confirmed.Functional testing found that the set leaked due to a small hole in the tubing adjacent to the tubing with the check valve.No damages or tools marks were observed with the packaging or the pca set during visual inspection.As the leak was reported to be observed during use and not during priming, it is unlikely that the leak was the result of a manufacturing or supplier issue.The root cause of the hole could not be definitively determined.
Event or Problem Description
It was reported that the iv tubing leaked and discovered there was a hole while in use on a patient.There was no patient harm.

• Brand Name: ALARIS® SYRINGE MODULE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8816919
• Report Number: 9616066-2019-02070
• Device Sequence Number: 343424
• Product Code: FPA
• UDI-Device Identifier: 10885403234385
• UDI-Public: 10885403234385
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/06/2019

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: 10/04/2021
• Device Model Number: 10800173
• Device Catalogue Number: 10800173
• Device Lot Number: 18105536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2019
• 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: DUALCAP ALCOHOL CAP,TD (B)(6) 2019
• Patient Age: 57 YR