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

Model Number	MX9166
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: 10ml bd syringe, ref 306547, lot 8263666, exp: 08/31/2021, 0.9% sodium chloride injection.The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
The customer reported that in the surgical oncology department a leak was noticed on the back side of the filter where there is an indentation.There was no report of harm.
Event or Problem Description
It was reported that in the surgical oncology department, a leak was noticed on the back side of the 0.2mm filter where there is an indentation.Although requested there was no further information provided by the customer.There was no report of patient harm.
Additional Manufacturer Narrative
Concomitant medical products: 10ml bd syringe ref 306547 lot 8263666 exp 2021-08-31 0.9% sodium chloride injection.The customer¿s report a leak was noticed on the back side of the filter was confirmed.No abnormalities were noted during visual inspection.Functional testing identified a leak from the 0.2 filter side weld line.The root cause of the weld line leak is due to a supplier manufacturing error.

• Brand Name: EXTENSION SET
• Common Device Name: SET,EXTENSION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8362742
• Report Number: 9616066-2019-00517
• Device Sequence Number: 13911691
• Product Code: FPA
• UDI-Device Identifier: 10885403237652
• UDI-Public: 10885403237652
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2019

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 Expiration Date: 02/13/2022
• Device Model Number: MX9166
• Device Catalogue Number: MX9166
• Device Lot Number: 17026438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1