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

Catalog Number	47233E
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that 3 bd alaris smartsite gravity set experienced roller clamp missing.The following information was provided by the initial reporter: account states that item #47233e is missing roller clamp and has excessive bubbles in line.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 31-mar-2023.H6: investigation summary: two samples were received for quality investigation.One of the samples received was unopened, still in the original packaging.The other sample was not in its original packaging.The customer complaint of misassembled was verified by visual examination.Comparing the samples received with the construction bill of materials indicate that the roller clamp of the assembly is missing on both samples.A device history record review for model 47233e lot number 22099387 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 misassemble is an issue at the manufacturing facility.The manufacturing facility conducted an investigation into the root cause of the issue seen with the sample.It was determined that the root cause of the issue was that the assembler was distracted and did not assemble the extension set correctly.
Event or Problem Description
It was reported that 3 bd alaris smartsite gravity set experienced roller clamp missing.The following information was provided by the initial reporter: account states tha item #47233e is missing roller clamp and has excessive bubbles in line.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16619957
• Report Number: 9616066-2023-00560
• Device Sequence Number: 5923873
• Product Code: FPA
• UDI-Device Identifier: 10885403235443
• UDI-Public: (01)10885403235443
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 07/11/2023

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 Catalogue Number: 47233E
• Device Lot Number: UNKNOWN
• 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: 03/08/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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