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

Catalog Number	MZ9278
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 extension set with needleless connector tubing separated at the blue joint during use.The following information was provided by the initial reporter, translated from french: "tubing comes off very easily (at the blue joint between the manual clan and the junction of the 3 tubings).Seen before connection to the bb, therefore without consequence but could have been very serious.Event that already happened a short time ago in the department.Took another octopus and check before installation".
Event or Problem Description
It was reported that the bd maxzero¿ multi-fuse extension set with needleless connector tubing separated at the blue joint during use.The following information was provided by the initial reporter, translated from french: "tubing comes off very easily (at the blue joint between the manual clan and the junction of the 3 tubings) seen before connection to the bb, therefore without consequence but could have been very serious event that already happened a short time ago in the department took another octopus and check before installation".
Additional Manufacturer Narrative
H6: investigation summary: a mz9278 sample was not available for investigation; however, the customer indicated the complaint sample was from lot 21099342.The feedback provided by the customer suggests the tubing disconnected prior to connection to the patient.As part of the feedback the customer provided a photograph; analysis of the photograph confirmed the customer's experience, as the back check valve component had broken in two, with part of it still solvent bonded to the tubing.The details of this feedback were forwarded to the manufacturing site for investigation.They confirmed that the root cause of the customer¿s experience could not be determined in this instance, as without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the damaged component.A review of the production records for lot 21099342 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.

• Brand Name: BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
• 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: 16659525
• Report Number: 9616066-2023-00606
• Device Sequence Number: 1700627
• Product Code: FPA
• UDI-Device Identifier: 10885403240812
• UDI-Public: 10885403240812
• 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
• Report Date (Section B): 06/19/2023

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
• Operator of Device: Other
• Device Expiration Date: 09/15/2024
• Device Catalogue Number: MZ9278
• Device Lot Number: 21099342
• 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: 03/15/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• 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