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

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
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.The event reportedly occurred in the nicu; therefore it is presumed the patient was a neonate.
Event or Problem Description
It was reported that the user noticed a maxplus extension set cracked at the male luer.The event occurred in the nicu.
Additional Manufacturer Narrative
The customer's report that the maxplus extension set cracked at the male luer was confirmed.Visual inspection of the set noted that a male luer tip was broken off.Closer inspection under magnification observed stress marks at the break site of the male luer tip.No tool marks were observed.Functional testing was deemed unnecessary due to the broken male luer tip and the obvious leak that would occur from the break.The root cause of the break is due to an outside force on the male luer tip as indicated by the observed stress marks at the break site.The root cause of the outside force could not be determined.
Event or Problem Description
It was reported that the user noticed a maxplus extension set cracked at the male luer.The event occurred in the nicu.

• Brand Name: MINIBORE EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8764722
• Report Number: 9616066-2019-01873
• Device Sequence Number: 1680329
• 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: 06/09/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/05/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1