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

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 the user noticed a maxplus extension set cracked at the male luer and a neutraclear connector stuck down when attached to a nicu patient.
Additional Manufacturer Narrative
Mdr 9616066-2019-01820 created in error.Investigation results for suspect model mp9251-c are reported under mdr 9616066-2019-01912.
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.

• Brand Name: MAXGUARD MINIBORE EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8774071
• Report Number: 9616066-2019-01820
• Device Sequence Number: 1689632
• 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: 07/09/2019
• Supplement Report FDA Received Date: 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, CUROS CAP