MAUDE Adverse Event Report: CAREFUSION EXT SET TRI-FUSE 7 W SLIDE CLAMP; INTRAVASCULAR ADMINISTRATION SET

Model Number	MZ9327
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that ext set tri-fuse 7 w slide clamp tubing would not flush.This occurred don 2 occasions.The following information was provided by the initial reporter: material #: mz9327, batch #: unknown.It was reported on the same day, two incidents product found to not flush.Two incidents of product mz9327 found to not flush.These were brand new from the package and one of the legs of the tri-fuse seemed fused internally and would not even prime with saline.
Additional Manufacturer Narrative
No sample or photo was provided was received by our quality team for evaluation, therefore; the customer's complaint of a damaged product/ inability to infuse could not be verified.A device history record review could not be performed on model mz9327 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported that ext set tri-fuse 7 w slide clamp tubing would not flush.This occurred don 2 occasions.The following information was provided by the initial reporter: material #: mz9327 batch #: unknown.It was reported on the same day, two incidents product found to not flush.Two incidents of product mz9327 found to not flush.These were brand new from the package and one of the legs of the tri-fuse seemed fused internally and would not even prime with saline.

• Brand Name: EXT SET TRI-FUSE 7 W SLIDE CLAMP
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10233420
• Report Number: 9616066-2020-02120
• Device Sequence Number: 2425470
• Product Code: FPA
• UDI-Device Identifier: 10885403427268
• UDI-Public: 10885403427268
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K905218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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: Other
• Device Model Number: MZ9327
• Device Catalogue Number: MZ9327
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 09/16/2020
• 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: 20200605; 20200605
• Outcome Attributed to Adverse Event: Other