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

Model Number	42100E-07
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd alaris smartsite gravity set the product was misassembled.There was no report of patient impact.The following information was provided by the initial reporter: some sets have the check valve (one-way valve) upside down.We found sets with the clear side up and white piece facing down, blocking the flow of fluid.Others were manufactured correctly with the white part facing up.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 14-mar-2023.H6: investigation summary one sample of material number 42100e-07 was received for quality investigation.The customer complaint of misassembly was verified by visual inspection.Evaluation of the sample submitted shows that the check valve is assembled backwards.A device history record review for model 42100e-07 lot number 22079485 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the failure is that the assembly procedure was not followed at the manufacturing facility.Investigation at the manufacturing facility has identified that an assembly fixture was not used during the assembly of the infusion set causing the check valve to be installed incorrectly.A quality alert was generated to prevent this defect in future production.
Event or Problem Description
It was reported while using bd alaris smartsite gravity set the product was misassembled.There was no report of patient impact.The following information was provided by the initial reporter: some sets have the check valve (one-way valve) upside down.We found sets with the clear side up and white piece facing down, blocking the flow of fluid.Others were manufactured correctly with the white part facing up.

• Brand Name: BD ALARIS SMARTSITE GRAVITY 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16566955
• Report Number: 9616066-2023-00482
• Device Sequence Number: 14885275
• Product Code: FPA
• UDI-Device Identifier: 50885403220607
• UDI-Public: (01)50885403220607
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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): 04/18/2023

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: 07/25/2025
• Device Model Number: 42100E-07
• Device Catalogue Number: 42100E-07
• Device Lot Number: 22079485
• 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: 02/24/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2022
• 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