MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S); INTRAVASCULAR ADMINISTRATION SET

Model Number	MZ9273
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that during use with bd maxzero multi-fuse extension set with needleless connector(s) was occluded.There was no report of patient impact.The following information was provided by the initial reporter: lumen with white clamp (used for lipid infusion) of trifurcate set will not flush.Extension set microbore trifuse, 3 bonded maxzero¿ needle-free connectors, 0.2 micron filter, 3 slide clamps (red, white, blue) , spin male luer lock.
Event or Problem Description
It was reported that during use with bd maxzero multi-fuse extension set with needleless connector(s) was occluded.There was no report of patient impact.The following information was provided by the initial reporter: lumen with white clamp (used for lipid infusion) of trifurcate set will not flush.Extension set microbore trifuse, 3 bonded maxzero¿ needle-free connectors, 0.2 micron filter, 3 slide clamps (red, white, blue) , spin male luer lock.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09-mar-2023.H6: investigation summary one used sample model# mz9273 was returned by the customer.He set was examined for defects and abnormalities.No defects or abnormalities were observed.A 10 ml bd syringe filled with water was attached to all 3 needleless connectors and was unable to be flushed.Possible excess solvent was seen near the male luer during the visual inspection under the microscope.A quality notification was sent to the manufacturer.From the manufacturers investigation, the occlusion between tubing and trifurcated was not found to be related to the hermosillo manufacturing process and the failure mode could not be replicated at this site to determine the root cause.Based on the photo provided by the vh dchu it cannot be guaranteed that what is seen inside of trifurcate is excess solvent.No corrective or preventive actions were defined because the potential root cause is not related with hermosillo manufacturing process.A device history record review could not be performed because a lot number was not provided by the customer.

• Brand Name: BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S)
• 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: 16500832
• Report Number: 9616066-2023-00355
• Device Sequence Number: 6221399
• Product Code: FPA
• UDI-Device Identifier: 50885403240858
• UDI-Public: (01)50885403240858
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• 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): 06/20/2023

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 Model Number: MZ9273
• Device Catalogue Number: MZ9273
• Device Lot Number: UNKNOWN
• 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: 02/08/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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