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

Catalog Number	MZ5305
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the bd maxzero multi-fuse pressure rated extension set with needleless connector(s) experienced foreign matter.The following information was provided by the initial reporter, translated from french to english: yellow tubing.
Additional Manufacturer Narrative
H6: investigation summary: a mz5305 sample was not available for investigation; however, the customer indicated the complaint sample was from lot 22069399.The feedback provided by the customer suggests the tubing on the maxzero extension set was yellow in colour.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 22069399 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Please note that yellow discolouration of the tubing can typically occur after irradiation sterilisation and the degree of discolouration can change over time and under certain storage conditions.This type of discolouration does not however affect the functionality of the device and therefore is considered to be a cosmetic defect.
Event or Problem Description
It was reported that the bd maxzero multi-fuse pressure rated extension set with needleless connector(s) experienced foreign matter.The following information was provided by the initial reporter, translated from french to english: yellow tubing.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: device available for eval?: yes.Returned to manufacturer on: 29-sep-2023.Investigation summary: three mz5303 samples were received in sealed packaging for investigation; two samples were from lot 22069399 and one sample from lot 23019170.The feedback provided by the customer suggests the tubing on the maxzero extension set was yellow in color.A visual inspection of the returned samples confirmed the customer's experience, as the samples received from lot 22069399 had a yellow tinge to the tubing, whilst the sample from lot 23019170 had clear tubing.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lots 22069399 and 23019170 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Please note that yellow discoloration of the tubing can typically occur after irradiation sterilization and the degree of discoloration can change over time and under certain storage conditions.This type of discoloration does not however affect the functionality of the device and therefore is considered to be a cosmetic defect.Although this is considered to be a rare occurrence, the quality team at the manufacturing site has been informed of this report in order to be aware of the reported feedback during future production of this product.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the mz5305 product in the international market over the past 12 months.
Event or Problem Description
It was reported that the bd maxzero multi-fuse pressure rated extension set with needleless connector(s) experienced foreign matter.The following information was provided by the initial reporter, translated from french to english: yellow tubing.

• Brand Name: BD MAXZERO MULTI-FUSE PRESSURE RATED 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17008294
• Report Number: 9616066-2023-01020
• Device Sequence Number: 20717441
• Product Code: FPA
• UDI-Device Identifier: 10885403230585
• UDI-Public: 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2023

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: 06/22/2025
• Device Catalogue Number: MZ5305
• Device Lot Number: 22069399
• 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: 05/05/2023
• Supplement Date Received by Manufacturer: 07/06/2023; 09/29/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 07/09/2023; 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• 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