MAUDE Adverse Event Report: CAREFUSION EXT SET W/VLV PORT & LL; INTRAVASCULAR ADMINISTRATION SET

Model Number	30204E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used 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 30204e lot number 20026167 was performed.The search showed that a total of 17,603 units in 1 lot number was built on (b)(6) 2020.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 ext set w/vlv port & ll leaked.The following information was provided by the initial reporter: material #: 30204e; batch #: 20026167.It was reported there was a leakage.No patient outcomes.Leaking was detected prior to attaching tubing to patient(s) and changed to non-leaking.The couple that were not detected prior to using on patient were not a problem because once it was attached to the iv catheter it was opened up and flowed as it should.The leaking was when trying to clamp off the extension tubing.No patient issues.Per our rn staff.

• Brand Name: EXT SET W/VLV PORT & LL
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10217971
• Report Number: 9616066-2020-02062
• Device Sequence Number: 11571536
• Product Code: FPA
• UDI-Device Identifier: 10885403235177
• UDI-Public: 10885403235177
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2020

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: 02/27/2023
• Device Model Number: 30204E
• Device Catalogue Number: 30204E
• Device Lot Number: 20026167
• 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: 07/01/2020
• 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