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

Model Number	11088483
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 10ml syringe, ref (b)(4), lot 8060885, exp (b)(6) 2021, 0.9% sodium chloride injection.The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
The customer reported that the filter cracked and leaked during patient use in nicu room 2.There was no report of patient harm.
Event or Problem Description
The customer reported that the filter cracked and leaked during patient use in nicu room 2.There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s report of a filter crack was not confirmed as the received set did not have a filter and this model is not manufactured with a filter.The customer¿s report of a leak was confirmed.Visual inspection showed that the female luer had a lateral crack.Closer inspection under magnification showed no tool marks or signs of over torque.The cause of the leak is a crack in the female luer component.The root cause of the crack could not be identified.

• Brand Name: MINIBORE/SMALLBORE EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8079516
• Report Number: 9616066-2018-02278
• Device Sequence Number: 1527436
• Product Code: FPA
• UDI-Device Identifier: 10885403234668
• UDI-Public: 10885403234668
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 10/26/2018

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: 11088483
• Device Catalogue Number: 11088483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 12/19/2018
• 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: 8110,8015, THERAPY DATE (B)(6) 2018; 8110,8015, THERAPY DATE (B)(6) 2018
• Patient Age: 7 DA