MAUDE Adverse Event Report: CAREFUSION ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	30893-07
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An unspecified issue reported by the customer was confirmed.The set was visually inspected for obvious damage such as incomplete bonding engagements, cracks, fractures, kinks, holes, and tears in the tubing and its components.A residual clear, colorless liquid was present within the set.No anomalies or evidence of damage on the set or components were observed upon initial visual inspection.Functional and pressure testing confirmed with varying degrees of speed/force and small droplets were observed at the engagement between the tubing and the inlet port of the male luer ¿patient hub¿.Examination under magnification revealed some solvent channels at the exterior tubing and interior male luer surfaces that seemed more evident along the area of the yellow stripe of the microbore tubing.The root cause is improper solvent application due to inadequate maintenance of the solvent dispenser and an improper holding time.This creates an inadequate interaction at the affected engagement that can lead to leaks after sterilization.
Event or Problem Description
It was reported that (2) sets are being sent in for investigation.The issue was unspecified, and therefore; there has been no impact to patient or additional information made available to date.

• Brand Name: ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9849576
• Report Number: 9616066-2020-01025
• Device Sequence Number: 14174793
• Product Code: FPA
• UDI-Device Identifier: 10885403460234
• UDI-Public: 10885403460234
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/05/2019

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: 02/06/2022
• Device Model Number: 30893-07
• Device Catalogue Number: 30893-07
• Device Lot Number: 19025228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1