MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD 32-IN STD BORE SET W/ MAX Y CONN; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX9175
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd 32-in std bore set w/ max y conn the tubing was defective.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that the product is defective.Details of complaint (reported issue): concern description: product failure.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 11-no-2022.H6: investigation summary: eight samples of material number mx9175 were submitted for quality investigation.The customer complaint of tubing defective/damaged was verified by inspection.Visual examination was first conducted on the sample to determine if there were any obvious signs of damage to the components or the assembly that may have been caused outside of the production process.There were no signs of physical damage to the assemblies.A test to see if the samples worked as intended was conducted.A sample bd 10 ml syringe was filled with water and connected to the extension sets.The water was then attempted to be pushed through the entire assembly from the female luer adapter all the way through the male luer adapter at the distal end.Only 1 sample (sample 1) worked as intended during the testing.The next test was to see if the occlusion was prevalent when trying to push fluid through the y-site component in the middle of the assembly.The proximal end of the tubing (female luer adapter) was capped so as not to allow flow up the tubing, but to direct flow to the open distal end male luer connector.Two samples worked as intended (sample 1 and 2), but the other 6 samples did not allow for flow past the smartsite.Based on the results of the testing, it was determined that excess bonding solvent was applied to the tubing and y-site connector causing the fluid path to be occluded.Under magnification it can be seen that the solvent is blocking the outlet port of the y-site and therefore causing the little to no flow conditions that we are observing in the samples.A device history record review for model mx9175 lot number 22079350 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.The root cause of the issue seen in this complaint is a defective smartsite valve in the construction.An investigation was conducted at the manufacturing facility.The investigation determined that the root cause was a failure in the assembly process to verify that the solvent dispenser was dispensing the correct amount of bonding solvent.The solvent dispenser was applying double the amount of bonding solvent causing the occlusion of the fluid path.A quality alert was generated to prevent the issue and ensure correct assembly of components.
Event or Problem Description
It was reported while using bd 32-in std bore set w/ max y conn the tubing was defective.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that the product is defective.Details of complaint (reported issue): concern description: product failure.

• Brand Name: BD 32-IN STD BORE SET W/ MAX Y CONN
• 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: 15721589
• Report Number: 9616066-2022-01673
• Device Sequence Number: 17954766
• Product Code: FPA
• UDI-Device Identifier: 10885403237676
• UDI-Public: 10885403237676
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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: 07/19/2025
• Device Catalogue Number: MX9175
• Device Lot Number: 22079350
• 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: 10/11/2022
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 11/03/2022
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2022
• 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