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

Catalog Number	MZ5301
Medical Device Problem Codes	Leak/Splash (1354); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxzero¿ extension sets experienced air bubbles.The following information was provided by the initial reporter, translated from french to english: on (b)(6) 2022, in the perioperative intensive care unit, during the installation of an infusion, the nursing team noticed the presence of air bubbles after the 6-valve manifold (ref.(b)(4) - lot 22f20-tjbnp) on which bidirectional valves are mounted.The leak appears to be coming from one of the valves that is being replaced.
Additional Manufacturer Narrative
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¿ extension sets experienced air bubbles.The following information was provided by the initial reporter, translated from french to english: on (b)(6) 2023, in the perioperative intensive care unit, during the installation of an infusion, the nursing team noticed the presence of air bubbles after the 6-valve manifold (ref.Rbp6315 - lot 22f20-tjbnp) on which bidirectional valves are mounted.The leak appears to be coming from one of the valves that is being replaced.
Additional Manufacturer Narrative
H6: investigation summary a mz5301 product was not available for investigation; and, the lot number of the complaint sample was reported unknown.The feedback provided by the customer suggests air bubbles were detected to be forming at the maxzero; however, no further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.

• Brand Name: BD MAXZERO¿ EXTENSION SETS
• 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 ; 8015296192
• MDR Report Key: 16080945
• Report Number: 9616066-2022-02101
• Device Sequence Number: 6294148
• Product Code: FPA
• UDI-Device Identifier: 10885403230547
• UDI-Public: 10885403230547
• 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): 02/27/2023

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 Catalogue Number: MZ5301
• Device Lot Number: UNKNOWN
• 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: 12/08/2022
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 12/30/2022
• Supplement Report FDA Received Date: 03/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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