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

Model Number	10010570
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 female luer crack.Visual inspection confirmed that the female luer had a lateral crack.Closer inspection under a lab microscope observed no tool marks or signs of over torque.Functional testing confirmed a leak from the observed crack.No other leaks were observed throughout the set.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection found a crack in the female luer wall on the opposite end of the injection gate of the set.The location of the luer gate on the female luer (at the ¿wings¿) indicates that this female luer was manufactured before the change order that moved the injection gate to a lower location to help mitigate and prevent female luer cracks.No tool marks or signs of over torque were observed.No damages were observed on the male luer.Functional testing resulted to a leakage from a cracked female luer.Device history record for model 10015817 could not be performed due to no lot number being provided by customer.The root cause of the crack is a result of internal stresses created in the luer during the manufacturing process that make it more susceptible to chemical/mechanical attacks.
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: 10376207
• Report Number: 9616066-2020-02450
• Device Sequence Number: 11498582
• Product Code: FPA
• UDI-Device Identifier: 10885403233500
• UDI-Public: 10885403233500
• 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: 10010570
• Device Catalogue Number: 10010570
• 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