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

Catalog Number	MZ5301
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 300 of the bd maxzero¿ extension set was difficult to disconnect.The following information was provided by the initial reporter, translated from swedish to english: luer lock connector gets stuck on the cvk.Need instrument to disconnect mz 5301.Customer sees a difference from older products and experiences difference for the worse.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: an mz5301 sample was not available for investigation; however, the customer indicated the complaint sample was from lot 21095727.The feedback provided by the customer suggests it was difficult to disconnect the male luer of the maxzero extension set from an unknown catheter due to the design of the male luer.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21095727 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.
Event or Problem Description
It was reported that 300 of the bd maxzero¿ extension set was difficult to disconnect.The following information was provided by the initial reporter, translated from swedish to english: luer lock connector gets stuck on the cvk.Need instrument to disconnect mz 5301.Customer sees a difference from older products and experiences difference for the worse.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 13jul2023.H6: investigation summary: two mz5301 samples were received for investigation; one sample was received without packaging, and one sample was received in sealed packaging from lot 21095727.The feedback provided by the customer suggests it was difficult to disconnect the male luer of the maxzero extension set from an unknown catheter due to the design of the male luer.A visual inspection of the returned samples did not identify any obvious damage or manufacturing defects which could have caused or contributed to the customer's experience.The samples were subjected to functional testing by connecting to a 50ml bd plastipak syringe and bd microlance 3 needle from stock, and priming with fluid; in each instance, a secure connection was established and no flow issues were detected.The microlance needle was then connected and disconnected from the extension set several times; again no connection or disconnection issues 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 21095727 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In this instance, a definitive root cause could not be identified as testing of the returned samples did not identify any product defects that could have contributed to the customers experience.However, the manufacturing site confirmed that the mz5301 product previously could be manufactured with two designs of male luer, however all future production of the mz5301 product will be manufactured with the luer design where the collar can not be slid down the length of the tubing.Please note the affected product was manufactured in september 2021, prior to the corrective action being implemented on the 30th of october 2021.
Event or Problem Description
It was reported that 300 of the bd maxzero¿ extension set was difficult to disconnect.The following information was provided by the initial reporter, translated from swedish to english: luer lock connector gets stuck on the cvk.Need instrument to disconnect mz 5301.Customer sees a difference from older products and experiences difference for the worse.

• Brand Name: BD MAXZERO¿ EXTENSION SET
• 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 ; 8448235433
• MDR Report Key: 16728982
• Report Number: 9616066-2023-00679
• Device Sequence Number: 20444503
• Product Code: FPA
• UDI-Device Identifier: 10885403230547
• UDI-Public: 10885403230547
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2023

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
• Operator of Device: Other
• Device Expiration Date: 09/13/2024
• Device Catalogue Number: MZ5301
• Device Lot Number: 21095727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 06/08/2023; 07/21/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 06/23/2023; 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2021
• 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