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	03/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 04/18/2023.D4: batch #: 822a59.Per photographic evaluation: this is an analysis of one photo submitted to ethicon endo surgery for evaluation.During the visual analysis, the following was observed: the photo shows a black reload from the top view with one gripping surface broken and still adhered to the body reload.Also, the swing tab is in unlocked position.Based on the photo the event described is confirmed.However, no conclusion or root cause could be determined.Please refer to the device analysis for full analysis details and conclusion.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned reload.Visual analysis of the returned sample determined, that the sr75 reload was received with the right gripping surface damaged, making the reload non-functional, and it was not returned analysis.No functional testing was performed, due to the condition of the reload.The event reported was confirmed.And it is related to improper use of the reload.The condition on the returned reload is consistent with an improper loading technique.When loading the cartridge in the device, make sure the cartridge is inside the channel track and proper loading.Please reference the instruction for use for more information.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 822a59.And no non-conformances were identified.
Event or Problem Description
It was reported,that the bd maxguard¿ extension set with needleless y-site and stopcock tubing was clogged.This is 3 of 3 related events.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 ".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: (b)(6) 2023 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.A device history record review for model mx4450 lot number (b)(6)was performed.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 h10.
Event or Problem Description
It was reported that the bd maxguard¿ extension set with needleless y-site and stopcock tubing was clogged.This is 3 of 3 related events.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 ".

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16762365
• Report Number: 9616066-2023-00716
• Device Sequence Number: 14218997
• 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): 07/19/2023

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: Health Professional
• Device Catalogue Number: MX4450
• Device Lot Number: 22099402
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 08/07/2023
• 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