MAUDE Adverse Event Report: CAREFUSION ALARIS 16 IN NON-DEHP EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MX9166
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2019
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
It was reported that, there was a leak from the back side of the filter from the built-in circle area.There was no patient harm.
Additional Manufacturer Narrative
The customer¿s report that there was a leak from the back side of the filter from the built-in circle area was confirmed on one of the two returned sets.However, the leak occurred at the filter¿s weld line.The sets were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Set 1 was observed to have white liquid within the set¿s tubing and 0.2 micron adult filter.Visual inspection of set 2 observed residual light brown fluid within the tubing.No visible damages or tool marks were observed.Functional testing was performed by attaching a 10ml bd lab syringe filled with blue dye water to set 1¿s female luer.The set was pressure tested and confirmed leak which was observed at filter¿s weld line.The root cause was due to a supplier manufacturing error by supplier.
Event or Problem Description
It was reported that there was a leak from the back side of the filter from the built-in circle area.There was no patient harm reported.

• Brand Name: ALARIS 16 IN NON-DEHP EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9241834
• Report Number: 9616066-2019-03037
• Device Sequence Number: 1611476
• Product Code: FPA
• UDI-Device Identifier: 10885403237652
• UDI-Public: 10885403237652
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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): 10/03/2019

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: 01/30/2024
• Device Model Number: MX9166
• Device Catalogue Number: MX9166
• Device Lot Number: 19017181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1