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

Catalog Number	MZ9277
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for additional lot number is as follows: medical device lot #: 20036653.Medical device expiration date: 20-mar-2023.Device manufacture date: 19-mar-2022.Medical device lot #: 22025498.Medical device expiration date: 10-feb-2025.Device manufacture date: 08-feb-2022.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 6 bd maxzero multi-fuse extension set with needleless connector(s) experienced leakage.The following information was provided by the initial reporter: we had two maxzero iv connectors fail in june.There was a leak at the max zero hub, and needed to be changed three times.
Additional Manufacturer Narrative
H6: investigation summary: samples were received and investigated by our quality team.No leak was realized with multiple attempts infusing saline solution with both syringe injection and infusing through other devices and no issue was detected.Due to no leakage, the complaint cannot be verified and the root cause remains unknown.The failure was due to the connected device when the leakage occurred.A device history record review was performed on material mz9277 for lots 20036653 (30mar2020 (b)(4) units produced) and 22025498 (10feb2022 (b)(4) units produced).There were no issues or quality notifications during the production of these sets.H3 other text : see h10.
Event or Problem Description
It was reported that 6 bd maxzero multi-fuse extension set with needleless connector(s) experienced leakage.The following information was provided by the initial reporter: we had two maxzero iv connectors fail in june.There was a leak at the max zero hub, and needed to be changed three times.

• 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: 15175226
• Report Number: 9616066-2022-01065
• Device Sequence Number: 6288771
• Product Code: FPA
• UDI-Device Identifier: 10885403240799
• UDI-Public: 10885403240799
• 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): 09/21/2022

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 Catalogue Number: MZ9277
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 09/30/2022
• 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