MAUDE Adverse Event Report: CAREFUSION MAXGUARD MINIBORE EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number	MP9251-C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
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 there was a break at the male luer on the maxplus and neutraclear valves stick down when attached to a nicu patient.
Additional Manufacturer Narrative
The customer¿s report that there was a break at the male luer on the maxplus extension set was confirmed by visual inspection.Also observed was stress marks and jagged/uneven edges at the break site.The products were visually inspected for obvious damage such as incomplete bonding engagements, cracks/fractures, kinks, holes, tears and any other anomalies.A residual light brown liquid was observed within the extension set.The male luer fixed collar was broken off from its base.Stress marks and jagged/uneven edges were observed at the break site of the broken collar.Functional testing could not be performed due to the broken collar and the inability to connect it securely to a mating component.Tool marks were present on the mid-body and at the female luer end, and the piston was still recessed, confirming the customer¿s report.No other evidence of damage or anomalies was observed.The root cause was not identified.
Event or Problem Description
It was reported that there was a break at the male luer on the maxplus and neutraclear valves stick down, when attached to a nicu patient.Although requested, there is no additional patient or event information available.

• Brand Name: MAXGUARD MINIBORE EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8778743
• Report Number: 9616066-2019-01868
• Device Sequence Number: 2540249
• 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: K051499
• 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
• 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
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1