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	MZ9292
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 1 bd maxzero multi-fuse extension set with needleless connector(s) experienced leakage.The following information was provided by the initial reporter: on a different note, there have been a few scenarios where rns have noticed fluid leaking near the max zero site.
Additional Manufacturer Narrative
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 1 bd maxzero multi-fuse extension set with needleless connector(s) experienced leakage.The following information was provided by the initial reporter: on a different note, there have been a few scenarios where rns have noticed fluid leaking near the max zero site.
Additional Manufacturer Narrative
H.6.Investigation: 2 max zero mz9292 connectors and a syringe were received and tested by our quality team.The connectors were visually inspected then tested with the syringe provided.The connectors were then infused with saline solution.No test showed abnormalities or leakages.There is an issue though in the past that has been noticed with connections between max zero and 3ml syringes.This issue has been escalated and treated with great urgency.In a parallel investigation, there were also 10 mz1000-07 ordered and tested with all syringes - 10 unused and 2 returned.Every one of these combinations leaked.The investigation found that the syringes were the culprit, rather than the mz, as the mz would not leak with other syringes.There were several samples sent for cae (computer aided engineering) analyses investigation in durham, nc.The ct scans conducted there found a leak path within the 3 ml syringe/mz connection, caused by an abnormal bump in the syringe luer wall.Functional testing and advanced scanning shows there are no anomalies or problem with the mz returned or ordered.The testing did find a molding anomaly with the 3 ml syringes, both returned and ordered, and the plant is conducting a further investigation.The samples tested here in vernon hills are being sent to the manufacturing location for further investigation.The manufacturing location will be taking ownership of the issue and determining if a project will need to be initiated.A device history record review for model mz9292 lot number 20095722 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of leakage with lot #20095722 regarding item #mz9292 a complaint history check was performed and this is the 2nd related complaint reported with the defect/condition of leakage regarding item #mz9292 over the 12 month period before this complaint.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12783378
• Report Number: 9616066-2021-52396
• Device Sequence Number: 5749646
• Product Code: FPA
• UDI-Device Identifier: 50885403417885
• UDI-Public: 50885403417885
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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 Model Number: MZ9292
• Device Catalogue Number: MZ9292
• Device Lot Number: 20095722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2020
• 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