MAUDE Adverse Event Report: CAREFUSION AS LVP BUR 20D 3SS; SET, ADMIN, INTRAVASCULAR

Model Number	10821753
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.Investigation summary: no product or photo was returned by the customer.The customer complaint of leakage could not be verified due to the product not being returned for failure investigation.A device history record review for model 10821753 lot number 20026322 was performed.The search showed that a total of 3,603 units in 1 lot number was built on 17feb2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Root cause analysis: the root cause of this failure was not identified as no product was returned.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that as lvp bur 20d 3ss leaked.The following information was provided by the initial reporter: it was reported that during an unspecified infusion therapy, leakage were observed on the burette set and 0.2 micron filter extension set.The infusion continued and completed the therapy.There was no patient harm and the leak did not cause harm to the healthcare provider.

• Brand Name: AS LVP BUR 20D 3SS
• Common Device Name: SET, ADMIN, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10203611
• Report Number: 9616066-2020-02044
• Device Sequence Number: 2246533
• Product Code: FPA
• UDI-Device Identifier: 07613203019187
• UDI-Public: 7613203019187
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 06/15/2020

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: 02/17/2023
• Device Model Number: 10821753
• Device Catalogue Number: 10821753
• Device Lot Number: 20026322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 16 YR
• Patient Weight: 79