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

Model Number	30893-07
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Not hispanic/latino.White.
Event or Problem Description
It was reported that the pcea tubing was leaking near the connection to patient's iv site.The connection was reported to be tight, and the medication dripped onto the patient's pillow.There was no patient harm.
Additional Manufacturer Narrative
Additional information added; b.7,& d.10.Correction; h.6.(patient code) the customer¿s report that the pcea tubing was leaking 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.Functional testing was performed and small droplets were observed at the engagement between the tubing and the inlet port of the male luer ¿patient hub¿.The set was then pressure tested and the set leaked at the noted leak location.No other leaks were observed.Further inspection 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 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.
Event or Problem Description
It was reported that the pcea tubing was leaking near the connection to the line in the patient.The connection was reported tight and the medication dripped out of the tubing onto the patient's pillow.Although requested, there has been no impact to patient response or additional event information made available to date.

• Brand Name: ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9513224
• Report Number: 9616066-2019-03690
• Device Sequence Number: 209564
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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: 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
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 03/02/2020
• 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: SYRINGE,8120,8015,THERAPY DATE 11/13/2019
• Patient Age: 39 YR
• Patient Weight: 89