MAUDE Adverse Event Report: CAREFUSION AS SYR PSD ASV 20D SMBORE SS 0.2M CV; INTRAVASCULAR ADMINISTRATION SET

Model Number	10798696
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2020
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 photo was received and complaint of broken plunger could not be verified.A device history record review for material no: 10798696 batch no: 19045397 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2019.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Root cause analysis: due to no sample being received, an investigation could not be performed and a root cause could not be determined.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 syr psd asv 20d smbore ss 0.2m cv plunger detached from the syringe.The following information was provided by the initial reporter: material no: 10798696, batch no: 19045397.It was reported that the plunger had detached from the syringe.Additional information (customer response) 11-aug-2020: what is the date the reported defect happened? (b)(6) 2020.Are the products involved in the event available for investigational purposes? no they were discarded.Was the tubing set attached to a patient at the time of the event or occurred during preparation/priming? occurred during preparation.Were there any adverse event(s) as a result of the reported defect? if yes, please provide details no harm to patient.Describe the event or problem infant patient had a versed drip infusing the bag to syringe closed system.When the nurse went to refill the syringe, the plunger had detached from the syringe there was no harm to the patient, but it did require a new setup.What was the original intended procedure? patient had versed infusing to protect airway.What problem did the user have (check all that apply) -device failed (e g.Broke, couldn't get it to work or stopped working).

• Brand Name: AS SYR PSD ASV 20D SMBORE SS 0.2M CV
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10445932
• Report Number: 9616066-2020-02568
• Device Sequence Number: 19848699
• Product Code: FPA
• UDI-Device Identifier: 10885403234354
• UDI-Public: 10885403234354
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• 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
• 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: Health Professional
• Device Expiration Date: 04/03/2022
• Device Model Number: 10798696
• Device Catalogue Number: 10798696
• Device Lot Number: 19045397
• 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: 08/24/2020
• 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: 2 MO