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 Consequences Or Impact To Patient (2199)
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
The customer reported that epidural tubing leaked below the luer lock adaptor during an infusion.There was no patient harm.
Additional Manufacturer Narrative
The customer¿s report that the epidural tubing leaked below the luer lock adapter was confirmed.Visual inspection of the set noted no discernible signs of damage or abnormalities.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.Functional and pressure testing confirmed leaking at the engagement of the tubing to the male luer adapter.The root cause was not identified.
Event or Problem Description
The customer reported that epidural tubing leaked below the luer lock adaptor during an infusion.There was no patient harm.

• 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: 7794204
• Report Number: 9616066-2018-01372
• Device Sequence Number: 19131516
• Product Code: FPA
• UDI-Device Identifier: 10885403273964
• UDI-Public: 10885403273964
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2018

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: 30893-07
• Device Catalogue Number: 30893-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 11/16/2018
• 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: 8120, 8015, BD 10ML SYRINGE, TD UNK