MAUDE Adverse Event Report: CAREFUSION AS LVP 20D DEHP AMBER SS 0.2M; INTRAVASCULAR ADMINISTRATION SET

Model Number	C24101E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that as lvp 20d dehp amber ss 0.2m tubing came apart.The following information was provided by the initial reporter: material no: c24101e, batch(lot) no: 19106851.It was reported that the tubing came apart at the distal end of the piece that goes into the alaris pump.Additional information (customer response) 10-aug-2020: what was the date and time of the event? (b)(6) 2020 4:30 pm.Was the tubing set attached to a patient at the time of the event or occurred during preparation/setup or when taken out of package? during preparation ¿ not attached to patient.If patient involvement; was there any effect on the patient from the event? no patient involvement.Was there a delay of, or change in, the course of treatment due to the event? please explain: no.Exposure to blood/bodily fluid/iv solution? if yes, please explain: no.
Additional Manufacturer Narrative
The following fields have been updated with corrections: b.3.Date of event: on (b)(6) 2020.
Event or Problem Description
It was reported that as lvp 20d dehp amber ss 0.2m tubing came apart.The following information was provided by the initial reporter: material no: c24101e, batch (lot) no: 19106851.It was reported that the tubing came apart at the distal end of the piece that goes into the alaris pump.Additional information (customer response) 10-aug-2020: 1.What was the date and time of the event? on (b)(6) 2020, 4:30 pm.2.Was the tubing set attached to a patient at the time of the event or occurred during preparation/setup or when taken out of package? during preparation not attached to patient.3.If patient involvement; was there any effect on the patient from the event? no, patient involvement.4.Was there a delay of, or change in, the course of treatment due to the event? please explain: no.5.Exposure to blood/bodily fluid / iv solution? if yes, please explain: no.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of tubing came apart could not be verified due to the product not being returned for failure investigation.The root cause of this failure was not identified as no product was returned.A device history record review for model c24101e lot number 19106851 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 30oct2019.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends h3 other text : see h10.
Event or Problem Description
It was reported that as lvp 20d dehp amber ss 0.2m tubing came apart.The following information was provided by the initial reporter: material no: c24101e batch(lot) no: 19106851 it was reported that the tubing came apart at the distal end of the piece that goes into the alaris pump.Additional information (customer response) (b)(6)-2020: 1.What was the date and time of the event? (b)(6)-2020 4:30 pm 2.Was the tubing set attached to a patient at the time of the event or occurred during preparation/setup or when taken out of package? during preparation ¿ not attached to patient.3.If patient involvement; was there any effect on the patient from the event? no patient involvement.4.Was there a delay of, or change in, the course of treatment due to the event? please explain: no 5.Exposure to blood/bodily fluid/iv solution? if yes, please explain: no.

• Brand Name: AS LVP 20D DEHP AMBER SS 0.2M
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10444542
• Report Number: 9616066-2020-02525
• Device Sequence Number: 4060602
• Product Code: FPA
• UDI-Device Identifier: 10885403235528
• UDI-Public: 10885403235528
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2020

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 Expiration Date: 10/30/2022
• Device Model Number: C24101E
• Device Catalogue Number: C24101E
• Device Lot Number: 19106851
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 08/28/2020; 10/05/2020
• 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: 20200806; 20200806
• Outcome Attributed to Adverse Event: Other