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

Catalog Number MZ5303

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2023

Event Type  malfunction  

Event Description

It was reported that the bd maxzero¿ multi-fuse pressure rated extension set with needleless connector had flow issues during use.The following information was provided by the initial reporter, translated from japanese: "the customer reported that using maxzero made the iv outflow worse.".

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Investigation summary: two mz5303 samples from lot 22045062 were received in opened packaging for investigation residual fluid was present in the products.The feedback provided by the customer suggests a flow restriction was detected during use of the maxzero extension set in connection with an unknown infusion set.As part of the feedback the customer provided photographs of the affected sample; analysis of the photographs in addition to a visual inspection of the returned samples did not identify any obvious damage or manufacturing issues which could have caused or contributed to the customer's experience.Functional testing was performed by connecting the returned samples to a 50ml bd plastipak syringe and attempting to flush with fluid; in each instance, no occlusions or flow restrictions were detected throughout testing.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 22045062 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.It was not possible to confirm the root cause of the customer¿s experience in this instance.Testing of the returned samples did not identify any product defects or quality deviations that could have contributed to the customer¿s experience.As the connecting product in use at the time of the reported occlusion was not available for investigation, it has not been possible to confirm if it may have contributed to the customer's experience.

Event Description

It was reported that the bd maxzero¿ multi-fuse pressure rated extension set with needleless connector had flow issues during use.The following information was provided by the initial reporter, translated from japanese: "the customer reported that using maxzero made the iv outflow worse.".

• Brand Name: BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR
• Type of Device: 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: 16777763
• MDR Text Key: 313836017
• Report Number: 9616066-2023-00734
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230561
• UDI-Public: 10885403230561
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

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
• Device Operator: Other
• Device Catalogue Number: MZ5303
• Device Lot Number: 22045062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1