MAUDE Adverse Event Report: CAREFUSION MAXPLUS EXTENSION SET

Model Number	MP9251-C
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.The event reportedly occurred in the nicu; therefore it is presumed the patient was a neonate.
Event or Problem Description
It was reported that maxplus extension was attached to neutraclear, upon closer observation the rn noticed that the extension set was cracked at the male luer when attached to a nicu patient.Although requested, no further details were provided by the customer for this event.
Event or Problem Description
It was reported that maxplus extension was attached to neutraclear, upon closer observation the rn noticed that the extension set was cracked at the male luer when attached to a nicu patient.Although requested, no further details were provided by the customer for this event.
Additional Manufacturer Narrative
The customer¿s report that the set was cracked at the male luer was confirmed.Visual inspection found that a male luer tip was found lodged into the female port of the neutraclear connector.Closer inspection under a microscope observed stress marks at the break site of the male luer tip.No tool marks were observed.An attempt to remove the male luer tip from the neutraclear was not successful.The root cause of the break is due to excessive force as indicated by the visible stress marks observed on the broken male luer tip.Previous investigations have shown that breaks may result from overtightening of the male luer on the mating component.In addition, if the male luer was overtightened upon connection, then it would have been difficult to disconnect the male luer from the mating component.An excess application of force may have been exerted upon disconnection, resulting in the breakage.Additionally, 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.
Event or Problem Description
It was reported that maxplus extension was attached to neutraclear, upon closer observation the rn noticed that the extension set was cracked at the male luer when attached to a nicu patient.Although requested, no further details were provided by the customer for this event.
Additional Manufacturer Narrative
The customer¿s report that the extension set was cracked at the male luer was confirmed.The set and neutraclear connector were visually inspected for cracks, misassemblies or damages to the components.Visual inspection found that a male luer tip was found lodged into the female port of the neutraclear connector.Closer inspection under a lab microscope observed stress marks at the break site of the male luer tip.No damage or issues were found on the neutraclear connector.No tool marks were observed.An attempt to remove the male luer tip from the neutraclear was not successful.Previous similar investigations have found that if the application of alcohol was not allowed proper time to dry when connecting the mating components.This could create a bond between the two components resulting in difficulties during disconnection.The breakage was caused by an external lateral force.The root cause of the external lateral force was not identified.

• Brand Name: MAXPLUS EXTENSION SET
• Common Device Name: MAXPLUS EXTENSION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8782602
• Report Number: 9616066-2019-01912
• Device Sequence Number: 16810803
• Product Code: FPA
• UDI-Device Identifier: 10885403237188
• UDI-Public: 10885403237188
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K171117
• 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,Followup,Followup
• Report Date (Section B): 06/13/2019

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: MP9251-C
• Device Catalogue Number: MP9251-C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 09/13/2019; 10/29/2019
• 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: PRI TUBING,EL-NC1001,1 CUROS CAP,TD UNK