MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXZERO¿ 1-WAY PRESSURE RATED EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ5305
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H3.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 on 2 occasions the bd maxzero¿ 1-way pressure rated extension set that the nurse was unable to purge the devices.The following information was provided by the initial reporter, translated from french to english: on 2 occasions, when about ten devices were in use, the nurse found it impossible to purge the devices.She was forced to change the device and use another.
Additional Manufacturer Narrative
Investigation summary: a mz5305 sample was not available for investigation; however the customer suggested the complaint sample was from lot 23029225.The feedback provided by the customer suggests a complete occlusion was detected during use of the maxzero extension set with a prefilled polymed syringe.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 23029225 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 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.
Event or Problem Description
It was reported that on 2 occasions the bd maxzero¿ 1-way pressure rated extension set that the nurse was unable to purge the devices.The following information was provided by the initial reporter, translated from french to english: on 2 occasions, when about ten devices were in use, the nurse found it impossible to purge the devices.She was forced to change the device and use another.

• Brand Name: BD MAXZERO¿ 1-WAY PRESSURE RATED 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17492754
• Report Number: 9616066-2023-01703
• Device Sequence Number: 15265596
• Product Code: FPA
• UDI-Device Identifier: 10885403230585
• UDI-Public: (01)10885403230585
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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: Health Professional
• Device Expiration Date: 02/14/2026
• Device Catalogue Number: MZ5305
• Device Lot Number: 23029225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2023
• 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