MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXZERO¿ NEEDLE-FREE VALVE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MZ1000

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 01/16/2023

Event Type  malfunction  

Event Description

It was reported while using bd maxzero¿ needle-free valve there was separation.There was no report of patient impact.The following information was provided by the initial reporter, translated from finnish to english: comes off easily, for example, when changing hoses or just cleaning the plug.

Manufacturer Narrative

Investigation summary: an mz1000 product was not available for investigation; however the customer indicated the complaint sample was from lot 22055431.The feedback provided by the customer indicates that they experienced disconnection of the maxzero following change of the infusion set.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 22055431 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as the complaint sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the maxzero component in the past 12 months.

• Brand Name: BD MAXZERO¿ NEEDLE-FREE VALVE
• 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 ; 8015296192
• MDR Report Key: 16328999
• MDR Text Key: 309200429
• Report Number: 9616066-2023-00163
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20885403224789
• UDI-Public: (01)20885403224789
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K132413
• 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
• Report Date: 01/19/2023

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: MZ1000
• Device Lot Number: 22055431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2023
• Initial Date FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2022
• 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