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

Catalog Number	MZ5301
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd maxzero multi-fuse pressure rated extension set was leaking the following information was received by the initial reporter with the following verbatim: the emergency post-reception unit has encountered problems with the following dm bd max zero lot 21105236: leakage at the level of the blue septum.A priori no impact for the patient.
Additional Manufacturer Narrative
Investigation results: one mz5301 sample from lot 21105236 was received in sealed packaging for investigation of pr 9517210.The customer reported that they experienced "leakage at the level of the blue septum".The returned samples were subjected to functional testing by priming and subjecting to an infusion using a 50ml bd plastipak syringe; no fluid leakage of air ingress was observed throughout testing, furthermore no damage or manufacturing defect was observed which may have contributed to the customer's experience.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21105236 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The customer¿s experience was not confirmed in this instance.Testing of the returned sample and a review of the production records did not identify any product defects or quality deviations during assembly.The alleged complaint sample was not available for investigation therefore it was not possible to confirm whether a manufacturing defect may have contributed to the reported leakage.A review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against the mz5301 product.
Event or Problem Description
No additional information.

• Brand Name: BD MAXZERO MULTI-FUSE 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18610211
• Report Number: 9616066-2024-00139
• Device Sequence Number: 11364200
• Product Code: FPA
• UDI-Device Identifier: 10885403230547
• UDI-Public: (01)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
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2024

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: 10/13/2024
• Device Catalogue Number: MZ5301
• Device Lot Number: 21105236
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown