MAUDE Adverse Event Report: CAREFUSION EXTENSION SETS; SET,ADMINISTRATION,INTRAVASCULAR

Model Number	20022
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.Although requested, patient demographics not provided.
Event or Problem Description
It was reported that microbore tubing was noted to be leaking in the pediatric area.Although requested, there were no further details or information provided and no report of harm.
Additional Manufacturer Narrative
The suspect extension set model 20022 lot unknown was not received from the customer for inspection and testing.Received from the customer were two new associate sealed in package extension sets model 20022 lot 19025720.The customer¿s report of the microbore tubing was noted to be leaking was not confirmed.The sets were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No abnormalities were observed on the sets during visual inspection.Functional testing showed no anomalies.The root cause of the customer's report could not be identified.
Event or Problem Description
It was reported that microbore tubing was noted to be leaking in the pediatric area.Although requested, there were no further details or information provided and no report of harm.

• Brand Name: EXTENSION SETS
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8746370
• Report Number: 9616066-2019-01798
• Device Sequence Number: 2040649
• Product Code: FPA
• UDI-Device Identifier: 10885403233265
• UDI-Public: 10885403233265
• 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,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

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 Model Number: 20022
• Device Catalogue Number: 20022
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1