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

Model Number	20028E
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device evaluated by mfr: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set tubing was defective.The following information was provided by the initial reporter: "we have saved some faulty tubing in which a rl report was placed".
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ extension set tubing was defective.The following information was provided by the initial reporter: "we have saved some faulty tubing in which a rl report was placed".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 19-jan-2023.H6: investigation summary: one sample was received for quality investigation.The customer complaint of misassembly was verified by visual inspection.Evaluation of the sample shows that that proximal female luer is missing from the assembly.Further examination of the sample indicates that there is a lack of solvent on the end of the tubing where the female luer connection should be.A device history record review for model 20028e lot number 22049384 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 lies in the manufacturing of the extension set.It cannot be determined if the female luer connector fell off during use or if the luer was not assembled on the extension set directly out of the packaging, however, the lack of solvent at the end of the tubing indicates an issue with the process of assembling the female luer connector to the tubing.An investigation at the manufacturing facility was conducted and it was identified that based on the lack of solvent seen at the end of the tubing the probable root cause is the omission of using the assembly fixture during assembly.

• Brand Name: BD ALARIS¿ SMARTSITE¿ EXTENSION 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: 16231042
• Report Number: 9616066-2023-00056
• Device Sequence Number: 20463588
• Product Code: FPA
• UDI-Device Identifier: 07613203012393
• UDI-Public: 07613203012393
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 03/07/2023

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 Model Number: 20028E
• Device Catalogue Number: 20028E
• 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: 01/04/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 03/19/2023
• 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