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

Catalog Number	42081E
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris smartsite gravity blood set tubing clamp was missing.The following information was provided by the initial reporter: customer reported that the tubing is missing a clamp.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary one sample was received for quality investigation.The customer complaint of misassembly was verified by visual inspection.Visual inspection of the sample received, and comparison of the build of material of the material number, indicate that there is a missing roller clamp from the tubing below the drip chamber.A device history record review for model 42081e lot number 23029232 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 of the failure seen in the sample is that the roller clamp was not added to the full assembly during the manufacturing process due to a failure of the assembler not using the proper fixture.Further investigation indicated that the assembly fixture was not used due to it being damaged and/or inverted.H3 other text : see h10.
Event or Problem Description
It was reported that the bd alaris smartsite gravity blood set tubing clamp was missing.The following information was provided by the initial reporter: customer reported that the tubing is missing a clamp.

• Brand Name: BD ALARIS SMARTSITE GRAVITY BLOOD 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: 17329893
• Report Number: 9616066-2023-01455
• Device Sequence Number: 5487528
• Product Code: FPA
• UDI-Device Identifier: 07613203020855
• UDI-Public: 07613203020855
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K882302
• 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): 10/05/2023

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: 02/14/2026
• Device Catalogue Number: 42081E
• Device Lot Number: 23029232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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