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

Catalog Number	42519E
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 2 bd alaris¿ smartsite¿ gravity sets were missing their roller clamps.The following information was provided by the initial reporter: " i have a few more of the 42519e iv sets that are defective.Two are missing the roller clamps".
Additional Manufacturer Narrative
Investigation summary: three samples were submitted for quality investigation.The customer complaint of misassembly was verified by visual inspection.Two of samples that were submitted did not have the roller clamp on the assembly.A device history record review for model 42519e lot number 22059085 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 missing roller clamps is a failure at the manufacturing facility during the assembly of the infusion set.An investigation was conducted at the manufacturing facility and it was determined that the missing roller clamp was caused because the correct fixture was not used during the assembly of the infusion set.
Event or Problem Description
It was reported that 2 bd alaris¿ smartsite¿ gravity sets were missing their roller clamps.The following information was provided by the initial reporter: " i have a few more of the 42519e iv sets that are defective.Two are missing the roller clamps.".

• 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 ; 8015296192
• MDR Report Key: 16319132
• Report Number: 9616066-2023-00143
• Device Sequence Number: 8813294
• Product Code: FPA
• UDI-Device Identifier: 07613203010870
• UDI-Public: 07613203010870
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/03/2023

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: 05/09/2025
• Device Catalogue Number: 42519E
• Device Lot Number: 22059085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• 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