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

Model Number	10014916
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.Although requested, patient demographics not provided.
Event or Problem Description
It was reported that the tubing separated from the filter while connected to a patient's brachial picc line.Although requested, there were no further details or information provided and no report of harm.
Additional Manufacturer Narrative
The customer¿s report that the tubing separated from the filter was not confirmed.Visual inspection of the set noted no damage or any anomalies.Examination under magnification of the filter observed the top assembly not fully secured to the bottom assembly.Functional testing confirmed leaking from the set's 0.2 micron ped filter weld.The root cause was determined to be due to a supplier issue of the ultrasonic weld area of the filter.
Event or Problem Description
It was reported that the tubing separated from the filter while connected to a patient's brachial picc line.Although requested, there were no further details or information provided and no report of harm.

• 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: 8755415
• Report Number: 9616066-2019-01833
• Device Sequence Number: 2043013
• Product Code: FPA
• UDI-Device Identifier: 10885403233920
• UDI-Public: 10885403233920
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 06/12/2019

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: 06/26/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 08/15/2019
• 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: NON-BD VALVE; PICC LINE,10ML ZR FLUSH SYRINGE, TD UNK