MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number	20022
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An unexpected return from the customer confirmed a male luer break.Visual inspection found that the male luer tip of model 20022 was broken off into the female luer of model 10015817.Closer inspection under a lab microscope observed stress marks at the break site of the male luer tip.No scratch marks or tool marks were observed on the extension set.The set was visually inspected for cracks, misassemblies or damages to the components.Closer inspection under a lab microscope observed stress marks at the break site of the male luer tip.No scratch marks or tool marks were observed on the extension set.Device history record for model 20022 could not be performed due to no lot number being provided by customer.The root cause of the male luer tip breakage could not be definitively determined.
Event or Problem Description
Product was received as an unexpected return with an unspecified failure.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10376206
• Report Number: 9616066-2020-02449
• Device Sequence Number: 2942159
• Product Code: FPA
• UDI-Device Identifier: 10885403233265
• UDI-Public: 10885403233265
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/19/2020

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 Model Number: 20022
• Device Catalogue Number: 20022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1