MAUDE Adverse Event Report: CAREFUSION NON-VENTED BLOOD SET

Model Number	2177-0000
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s report that the blood tubing came apart was confirmed.Visual inspection of the set noted separation at the engagement between one of the set's two quickspikes and tubing components.Examination of the separated tubing end observed insufficient to no solvent traces and evidence that the tubing was not fully inserted into the outlet of the quickspike.Functional testing was deemed unnecessary due to the obvious separation.Dimensional analysis of the separated tubing end was observed to be within specification.The rest of the set's tubing engagements were slightly tugged in which no separations were observed.The root cause was identified as a manufacturing issue due to insufficient solvent being applied at the engagement of the tubing.
Event or Problem Description
It was reported that the blood tubing came apart prior to patient use.No harm to patient.

• Brand Name: NON-VENTED BLOOD SET
• Common Device Name: BLOOD SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9109799
• Report Number: 9616066-2019-02692
• Device Sequence Number: 11659710
• Product Code: FPA
• UDI-Device Identifier: 07613203012652
• UDI-Public: 7613203012652
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K894842
• 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
• Report Date (Section B): 09/02/2019

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: 06/13/2022
• Device Model Number: 2177-0000
• Device Catalogue Number: 2177-0000
• Device Lot Number: 19066119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1