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

Catalog Number	20062E
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone#: unknown.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 the blue connection port on the bd alaris¿ smartsite¿ extension set was found depressed upon opening the package, and remained so after flushing the line.The following information was provided by the initial reporter: "needle free valve of trifuse packaged was malfunctioned upon opening.Blue connection port that is usually depressed (opening the system) when connected to needleless connectors was depressed upon opening package.Line was flushed and the port still remained depressed.These connections do not require a cap and would leave line port accessed while connected to patient.Additional information received 01-nov-2022.Was the product used? it was only primed, not used on patient.It was mentioned that there was potential harm.Was there any actual patient harm/impact? no.Is the product contaminated with chemo? no.".
Additional Manufacturer Narrative
H6: investigation summary one sample was received for quality investigation.The customer complaint of component damage was verified by inspection.Evaluation of the sample received shows that one of the smartsites in the assembly is stuck in the open position.A needleless syringe was inserted into the smartsite in order to see if the smartsite would then go back to normal operation after moving the blue insert.After removing the needless syringe, the blue insert in the smartsite valve remained in the open position.Further examination does not indicated excessive solvent in the component or any debris that may be restricting the movement of the smartsite insert.A device history record review for model 20062e lot number 20096038 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 18sep2020.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 piston of the smartsite not closing was caused by the smartsite body being out of dimension, which causes the smartsite to look like it is open, when it is actually in its normal position.A quality notification has been created in order to correct this issue.The quality notification included the molding team performing corrective maintenance in the mold of the molding machine for the smartsite body.This corrective maintenance was conducted after the creation of the reported lot number of this extension set.
Event or Problem Description
It was reported that the blue connection port on the bd alaris¿ smartsite¿ extension set was found depressed upon opening the package, and remained so after flushing the line.The following information was provided by the initial reporter: "needle free valve of trifuse packaged was malfunctioned upon opening.Blue connection port that is usually depressed (opening the system) when connected to needleless connectors was depressed upon opening package.Line was flushed and the port still remained depressed.These connections do not require a cap and would leave line port accessed while connected to patient.Additional information received 01-nov-2022 was the product used? it was only primed, not used on patient.It was mentioned that there was potential harm.Was there any actual patient harm/impact? no.Is the product contaminated with chemo? no".

• 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: 15830475
• Report Number: 9616066-2022-01784
• Device Sequence Number: 14727557
• Product Code: FPA
• UDI-Device Identifier: 07613203011853
• UDI-Public: (01)07613203011853
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/19/2022

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: 09/18/2023
• Device Catalogue Number: 20062E
• Device Lot Number: 20096038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 11/19/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2020
• 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