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

Model Number	MX4410
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported that the set was missing a hub on the end of the tubing.Although requested, no further details were provided by the customer for this event.The event occurred in the surgical acute care.
Additional Manufacturer Narrative
The customer¿s complaint of set was missing a hub on the end of the tubing was confirmed.During visual inspection, it was observed that the male luer spin lock was completely missing from the distal end to tubing.No other issues were observed.The distal end of the tubing that connects to the male luer was observed to have no solvent applied at the tubing engagement.Functional testing was not necessary as it is obvious that a leak would occur as a result of the missing component.The root cause was identified as assembly sequence not being followed during the manufacturing process.
Event or Problem Description
It was reported that the set was missing a hub on the end of the tubing.Although requested, no further patient or event details were provided by the customer.The event occurred in the (sac) surgical acute care unit.

• Brand Name: ALARIS ADMINISTRATION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9168111
• Report Number: 9616066-2019-02784
• Device Sequence Number: 19523795
• Product Code: FPA
• UDI-Device Identifier: 10885403237454
• UDI-Public: 10885403237454
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 04/30/2024
• Device Model Number: MX4410
• Device Catalogue Number: MX4410
• Device Lot Number: 19047081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1