MAUDE Adverse Event Report: CAREFUSION MICROBORE EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number	10010570
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: 10 ml bd syringe of nacl, lot 8044680, exp 2021-01-31, therapy date: (b)(6) 2018.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.
Event or Problem Description
The customer reported a leak at the filter of the tubing that was infusing an unspecified medication.It is unknown if this contributed to the patient developing a clabsi (central line-associated bloodstream infection) on (b)(6) 2018.There was no intervention or lasting harm reported.
Additional Manufacturer Narrative
The customer¿s report of a leak at the filter was confirmed.Visual inspection under magnification showed that the 0.2 micron filter had a crack along the side weld line between the upper and lower housing on the filter¿s input port side.No tool or stress marks were observed on the filter component.Functional and pressure testing confirmed leaking from the crack.The cause of the leak was a crack along the filter component¿s side weld line.The root cause of the crack was not determined.
Event or Problem Description
The customer reported a leak at the filter of the tubing that was infusing an unspecified medication.It is unknown if this contributed to the patient developing a clabsi (central line-associated bloodstream infection) on (b)(6) 2018.There was no intervention or lasting harm reported.
Event or Problem Description
The customer reported a leak at the filter of the tubing that was infusing an unspecified medication.It is unknown if this contributed to the patient developing a clabsi (central line-associated bloodstream infection) on (b)(6) 2018.There was no intervention or lasting harm reported.

• Brand Name: MICROBORE EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7685809
• Report Number: 9616066-2018-00986
• Device Sequence Number: 1398811
• Product Code: FPA
• UDI-Device Identifier: 10885403233500
• UDI-Public: 10885403233500
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10010570
• Device Catalogue Number: 10010570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 08/16/2018; 10/08/2018
• 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: MZ1000-07,CENTRAL LINE, THERAPY DATE: (B)(6) 2018; THERAPY DATE (B)(6) 2018; MZ1000-07,CENTRAL LINE, THERAPY DATE: (B)(6) 2018
• Outcome Attributed to Adverse Event: Other