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

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
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
It was reported leaking pcea tubing.The nurse was concerned about patient safety as the tubing for the epidural was leaking.Although requested, additional information has not been provided.This file is for (b)(6).
Event or Problem Description
It was reported there was leaking with the pcea tubing.The nurse was concerned about patient safety as the tubing for the epidural was leaking.Although requested, there has been no impact to patient response or additional event information made available to date.This file is for la jolla.
Additional Manufacturer Narrative
The customer¿s report of pcea tubing leaking was confirmed.No anomalies or evidence of damages were observed upon initial visual inspection.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 damages were observed upon initial visual inspection the leak occurred at the engagement between the microbore tubing and the male luer adapter.Further observation under microscope revealed some solvent anomalies that seemed more evident along the area of the yellow stripe of the microbore tubing.Functional testing was performed and small droplets were observed at the engagement between the tubing and the inlet port of the male luer.The set was then pressure tested and the set leaked at the previously noted leak along the yellow stripe on the tubing.Although there are multiple contributing factors, the predominant 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.

• Brand Name: ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING
• Common Device Name: SET,ADMINISTRATION,INTRASVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9571901
• Report Number: 9616066-2020-00006
• Device Sequence Number: 381727
• Product Code: FPA
• UDI-Device Identifier: 10885403460234
• UDI-Public: 10885403460234
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2022
• Device Model Number: 30893-07
• Device Catalogue Number: 30893-07
• Device Lot Number: 19025136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1