MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ARTERIAL SMARTSITE¿ NEEDLE-FREE VALVE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	2000EA
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: investigation summary: 996 unopened samples (model #2000ea, lot #23015487) were returned by the customer.It was reported by customer that the bd ea luer lock sites are occluding and keeping the fluids from running into the patient.Evaluation of 59 samples were performed.The sample size quantity was determined per 1701-008-000 swi sample size selection work instruction v.08.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The samples were connected to a cut off syringe tip to check that the fluid path is in an activated position/open when connected to a syringe.The samples were then attempted to be flushed with water using a 10ml bd syringe to confirm an open fluid path.The fluid paths of 57 of the samples were open and those samples were able to be flushed.The failure was unable to be replicated in these samples.The fluid paths of 2 of the samples were not open and were unable to be flushed.The customer complaint can be verified in these samples.A quality notification was sent to the manufacturer, and samples were sent for further investigation.The manufacturer was able to confirm the failure.Further investigation determined that the potential root cause could be related to the variation of the fluoriosilicone application, although, according to the validation of the process, the technology used allows a number of defective parts due to this condition.A quality alert was created on july 19th, 2023 and communicated by the production supervisor to the involved personnel to reinforce the correct fluorosilicone weighing, and that the operators need to notify to the mechanic and / or manufacturing and quality engineering to correct the problem or in this case, to adjust the amount of fluorosilicone that the machine is applying when the fluorosilicone values are so close to the minimum / or maximum control limits.A device history record review for model 2000ea lot number 23015487 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 19jan2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h.10.
Event or Problem Description
It was reported while using bd arterial smartsite¿ needle-free valve there was a clog.There was no report of patient impact.The following information was provided by the initial reporter: per customer, ¿we are having problems with the bd 2000ea luer lock sites.They are occluding and keeping the fluids from running into the patient.Nursing staff and the cno have reported that the bd 2000ea luer loc sites will not let the fluids run.They have unhooked the tubings and the fluids will run fine if not going through the bd luer lock site.I would like to return what i have purchased.I have 4 cases still in their original boxes and then approximately another case in ziplock bags that we dispense with.The nursing dept and er will probably have more but i don't know that number yet.Would you be able to tell me how many we have purchased from cardinal? i have purchased from shared also and am working with them also.¿ could you please help to provide the exact quantity of affected batch? i have 8 cases of 10, still in boxes.I have 96 ea in a ziplock that has been returned from departments.2.Is there any sample available? if yes, kindly provide the facility address for us to generate the return label.If no, kindly provide a photo.Yes there is left over stock but not the actual valves.(b)(6) hospital, (b)(6).3.What is the patient outcome? is there any adverse event/serious injury? antibiotic deliveries were delayed, when the smartsite valves were changed out to the icu medical brand theiv flowed freely with no occlusion error.4.Was there a delay of, or change in, the course of treatment due to the event? yes, iv fluid bolus, zosyn and azithromycin infusions were delayed.5.What type of procedure is being performed? iv fluid boluses and iv antibiotics, ie zosyn and azithromycin infusions.6.What was medication being used in the procedure? zosyn and azithromycin.Evaluation of 59 samples were performed.The sample size quantity was determined per 1701-008-000 swi sample size selection work instruction v.08.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The samples were connected to a cut off syringe tip to check that the fluid path is in an activated position/open when connected to a syringe.The samples were then attempted to be flushed with water using a 10ml bd syringe to confirm an open fluid path.The fluid paths of 57 of the samples were open and those samples were able to be flushed.The failure was unable to be replicated in these samples.The fluid paths of 2 of the samples were not open and were unable to be flushed.The customer complaint can be verified in these samples.A quality notification was sent to the manufacturer, and samples were sent for further investigation.The manufacturer was able to confirm the failure.Further investigation determined that the potential root cause could be related to the variation of the fluoriosilicone application, although, according to the validation of the process, the technology used allows a number of defective parts due to this condition.A quality alert was created on july 19th, 2023 and communicated by the production supervisor to the involved personnel to reinforce the correct fluorosilicone weighing, and that the operators need to notify to the mechanic and / or manufacturing and quality engineering to correct the problem or in this case, to adjust the amount of fluorosilicone that the machine is applying when the fluorosilicone values are so close to the minimum / or maximum control limits.

• Brand Name: BD ARTERIAL SMARTSITE¿ NEEDLE-FREE VALVE
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17452676
• Report Number: 9616066-2023-01635
• Device Sequence Number: 12584962
• Product Code: FPA
• UDI-Device Identifier: 27613203021689
• UDI-Public: (01)27613203021689
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 08/03/2023

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: 01/18/2026
• Device Catalogue Number: 2000EA
• Device Lot Number: 23015487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2023
• 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