MAUDE Adverse Event Report: CAREFUSION AS LVP BUR 20D 3VS; INTRAVASCULAR ADMINISTRATION SET

Model Number	10779313
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that as lvp bur 20d 3vs separated and leaked.The following information was provided by the initial reporter: material no:1077-9313 batch no: unknown.It was reported that plastic cap on top of buretrol separated causing chemo spills.Initial notice: we recently began using our original buretrols.We have since had issues where the plastic cap at the top of the buretrol has come off.This has happened 3 times now in the last past 2 weeks- all resulting in chemo spills and the need to prepare new doses.
Additional Manufacturer Narrative
Two photos were received by our quality team for evaluation.Upon visual inspection, it was observed that the plastic cap separated; therefore, the incident could be verified.A device history record review could not be performed on model 10779313 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.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 3vs separated and leaked.The following information was provided by the initial reporter: material no:1077-9313 batch no: unknown.It was reported that plastic cap on top of buretrol separated causing chemo spills.Initial notice: we recently began using our original buretrols.We have since had issues where the plastic cap at the top of the buretrol has come off.This has happened 3 times now in the last past 2 weeks- all resulting in chemo spills and the need to prepare new doses.

• Brand Name: AS LVP BUR 20D 3VS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10395797
• Report Number: 9616066-2020-02382
• Device Sequence Number: 3167609
• Product Code: FPA
• UDI-Device Identifier: 10885403234279
• UDI-Public: 10885403234279
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 07/20/2020

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: Other
• Device Model Number: 10779313
• Device Catalogue Number: 10779313
• Device Lot Number: UNKNOWN
• 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: 08/12/2020
• Supplement Report FDA Received Date: 10/09/2020
• 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