MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MPX5304-C
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd maxplus pressure rated extension set with removable needleless connector it was blocked.The following was received by the initial reporter: customer stating iv didn't flow through t-piece.No adverse events.
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
B5: additional information received from customer added.Investigation results: one sample model mpx5304-c lot 22069544 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The sample was attached to a 10 bd syringe and attempted to be flushed.The sample was unable to be flushed.No excess solvent was observed upon a visual inspection under a microscope.The silicone of the needless connector was blocking the tubing.A quality notification was sent to the manufacturer.From the manufacturers investigation, the possible root cause is that during the assembly the nac-y arm did not stop at the component stop.A quality alert was generated on november 10th, 2023 to reinforce the correct tubing assembly method.A device history record review for model mpx5304-c lot number 22069544 was performed.The search showed that a total of (b)(4) in 1 lot number was built on 25jun2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Additional information received from customer: was the tubing set attached to a patient at the time of the event or occurred during preparation/priming? no.Was the tubing still coiled with tape in place during priming/flushing? unknown.Was there any adverse event or serious injury reported? no.

• Brand Name: BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17607871
• Report Number: 9616066-2023-01785
• Device Sequence Number: 6307532
• Product Code: FPA
• UDI-Device Identifier: 20885403237246
• UDI-Public: (01)20885403237246
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 06/23/2025
• Device Catalogue Number: MPX5304-C
• Device Lot Number: 22069544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2022
• 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