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

Model Number	ME2050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Concomitant medical products: port - picc line.The event occurred at children's hospital presumed patient to be an infant, child or adolescence.
Event or Problem Description
It was reported that male-end connector broke off inside the smartside end cap.There customer stated; "i have no other information as requested".Although patient impact was requested it was not provided.A note received with product that stated, "check end cap with piece stuck inside- broke end cap and broken intermittent tubing.While disconnecting the int tubing from the end cap on patient picc line, both end caps broke off.The patient was due for a cap change anyway but changed the end cap.".
Additional Manufacturer Narrative
Additional information added to: b7, & d11.*********************************************** the customer¿s reports that male-end connector broke off inside the smartsite end cap was confirmed.The set was visually inspected for cracks, misassemblies or damages to the components.Visual inspection found that a male luer collar was broken off and that the male luer tip was broken off into one of the received smartsite connectors.Closer inspection under a lab microscope observed stress marks at the break site of the male luer.No tool marks were observed.The broken male luer was not expected to have occurred during assembly as the break was observed during use.In addition, previous similar investigations have found that if the application of alcohol was not allowed proper time to dry when connecting the mating components, it could create a bond between the two components resulting in difficulties during disconnection.No further testing could be performed due to the broken male luer tip.The root cause of the break could not be definitively determined.
Event or Problem Description
It was reported that the male-end connector broke off inside the smartside end cap.The customer stated; " i have no other information as requested." although inquiry to patient impact was requested, but it was not provided.(a note received with product that stated ; "check end cap with piece stuck inside- broke end cap and broken intermittent tubing.While disconnecting the int tubing from the end cap on patient picc line, both end caps broke off.The patient was due for a cap change anyway but changed the end cap".).

• 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: 9349822
• Report Number: 9616066-2019-03355
• Device Sequence Number: 16696696
• Product Code: FPA
• UDI-Device Identifier: 10885403236266
• UDI-Public: 10885403236266
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2019

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: ME2050
• Device Catalogue Number: ME2050
• 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: 11/20/2019
• Supplement Report FDA Received Date: 02/19/2020
• 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: MEDEX SYRINGE PUMPS,3M CUROS, ENDOCARPS,TD (B)(6) 2019; PRI TUBING,(2)2000E