MAUDE Adverse Event Report: CAREFUSION 17 INCH EXT W/.2 FLTR & VLV PORT; INTRAVASCULAR ADMINISTRATION SET

Model Number	20028E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Electrolyte Imbalance (2196)
Date of Event	08/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint of the filter cracking and leaking could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 20028e because an invalid lot number was provided by the customer.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.Investigation.
Event or Problem Description
It was reported that 17 inch ext w/.2 fltr & vlv port was cracked and leaked.The following information was provided by the initial reporter: material no: 20028e batch no: unknown.It was reported smart site extension filter cracked with leakage; baby had electrolyte issues.
Additional Manufacturer Narrative
The following fields have been updated with corrections: b.1.Adverse event and/or product problem (e.G., defects/malfunctions): adverse event and product problem.H.1.Type of reportable event: serious injury.
Event or Problem Description
It was reported that 17 inch ext w/.2 fltr & vlv port was cracked and leaked.The following information was provided by the initial reporter: material no: 20028e, batch no: unknown.It was reported smart site extension filter cracked with leakage; baby had electrolyte issues.

• Brand Name: 17 INCH EXT W/.2 FLTR & VLV PORT
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10457027
• Report Number: 9616066-2020-02577
• Device Sequence Number: 2676558
• Product Code: FPA
• UDI-Device Identifier: 07613203012393
• UDI-Public: 7613203012393
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 20028E
• Device Catalogue Number: 20028E
• 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: 08/26/2020
• Supplement Report FDA Received Date: 08/27/2020
• 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: 8110,8015,
• Outcome Attributed to Adverse Event: Other