MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD¿ EXTENSION SET WITH NEEDLELESS Y-SITE AND STOPCOCK; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX4450
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 bd maxguard¿ extension set with needleless y-site and stopcock had flow issues and could not be flushed or primed with saline.The following information was provided by the initial reporter: "tubing cannot be flushed or primed."i have received 3 defective mx4450 bd maxguard extension set with two 4-way stopcocks and needleless y-site, initially received on 3/13 and then two more on 3/17, all 3 from pre-op acu.These all do not work.They cannot be flushed and or primed.Customer reported an additional mx4450 issues and have an additional set received on 3/30 from labor and delivery.Were there any adverse events due to the reported issue? no adverse events.Was any medication used with the product? if yes, what was the medication? no.Medications? only saline.
Additional Manufacturer Narrative
H6: investigation summary : one sample model mx4450 lot 22099402 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was attached to a 10 ml bd syringe and unable to be flushed.Visual inspection under the microscope showed signs of excess solvent near the female luer.A quality notification was sent to the manufacturer.From the manufacturers investigation, operator did not follow the procedure mfg0225 for mdgn dispenser and insert multiple the tube into solvent dispenser.A quality alert was generated on (b)(6) 2023 to prevent this defect.No corrective/preventive actions were taken on this investigation since the controls to prevent occlusion in tubing were in place.A device history record review for model mx4450 lot number 22099402 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
It was reported that the bd maxguard¿ extension set with needleless y-site and stopcock had flow issues and could not be flushed or primed with saline.The following information was provided by the initial reporter: "tubing cannot be flushed or primed."i have received 3 defective mx4450 bd maxguard extension set with two 4-way stopcocks and needleless y-site, initially received on (b)(6) and then two more on (b)(6), all 3 from pre-op acu.These all do not work - they cannot be flushed and or primed.Customer reported an additional mx4450 issues and have an additional set received on (b)(6)from labor and delivery.Were there any adverse events due to the reported issue? no adverse events.Was any medication used with the product? if yes, what was the medication? no medications - only saline".

• Brand Name: BD MAXGUARD¿ EXTENSION SET WITH NEEDLELESS Y-SITE AND STOPCOCK
• 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 ; 8448235433
• MDR Report Key: 16842361
• Report Number: 9616066-2023-00782
• Device Sequence Number: 18010208
• Product Code: FPA
• UDI-Device Identifier: 10885403274671
• UDI-Public: 10885403274671
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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 Catalogue Number: MX4450
• Device Lot Number: 22099402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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