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	MZ9295
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Medical device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd maxzero multi-fuse extension set with needleless connector(s) leaked.The following information was provided by the initial reporter: " leaking from the y-connector where it is connected to medication tubing".
Additional Manufacturer Narrative
H.6.Investigation summary: 1 max zero connector set and one 3ml bd syringe were received for investigation by our quality team.The max zero connectors were not present in the set when received.The set was tested multiple times to try to induce leak but none was noticed.There has been a known issue of leakage between the 3ml syringes and maxzero so the complaint has been verified.The root cause is not due to the maxzero but due to the syringe specifically when connected to the maxzero.The production facility is aware of this and is working to eliminate future occurrences of leakage with this connection.A device history record review could not be performed because a lot number was not provided by the customer.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
It was reported that bd maxzero multi-fuse extension set with needleless connector(s) leaked.The following information was provided by the initial reporter: "leaking from the y-connector where it is connected to medication tubing".

• 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 ; 8015296192
• MDR Report Key: 13544035
• Report Number: 9616066-2022-00135
• Device Sequence Number: 20093386
• Product Code: FPA
• UDI-Device Identifier: 50885403417915
• UDI-Public: 50885403417915
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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: MZ9295
• Device Catalogue Number: MZ9295
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 07/22/2022
• 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