MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS SMARTSITE W/MANIFOLD GRAVITY & EXT SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	42511E
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd alaris smartsite w/manifold gravity & ext set there was a blockage.There was no report of patient impact.The following information was provided by the initial reporter: customer reported the tubing does not prime due to valve being placed on backwards.Was there any patient involvement? na.If yes, what is the patient outcome? na.Is there any adverse event/serious injury? na.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd alaris smartsite w/manifold gravity & ext set there was a blockage.There was no report of patient impact.The following information was provided by the initial reporter: customer reported the tubing does not prime due to valve being placed on backwards.Was there any patient involvement? na if yes, what is the patient outcome? na is there any adverse event/serious injury? na.
Additional Manufacturer Narrative
The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 07-aug-2023 investigation summary a complaint of sample being unable to be primed due to a backcheck valve being misassembled was received from the customer.A sample was returned for investigation.Through visual inspection, the customer complaint of misassembly was confirmed.The backcheck valve was assembled so that the red side was towards the drip chamber.A device history record review for model 42511e lot number 22119415 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A review of the assembly process was performed, and it was found that the root cause of this defect is due to assembler not using the orientation fixture.

• Brand Name: BD ALARIS SMARTSITE W/MANIFOLD GRAVITY & EXT SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17466763
• Report Number: 9616066-2023-01648
• Device Sequence Number: 12508233
• Product Code: FPA
• UDI-Device Identifier: 50885403235410
• UDI-Public: (01)50885403235410
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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 Expiration Date: 11/29/2025
• Device Catalogue Number: 42511E
• Device Lot Number: 22119415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown