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

Catalog Number	MZ5301
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A mz5301 product was not available for investigation; furthermore the lot number was not provided by the customer.The feedback provided by the customer indicates a flow restriction was detected during use of the maxzero¿ extension set.Further information provided by the customer confirmed that there were no damages on the set and the flow was restricted during infusion of paclitaxol drug.Additionally, they confirmed that the medication was quite viscous and hence, it was harder to deliver through this extension set compared with a larger bore extension set.The details of this feedback were forwarded to the manufacturing site for investigation; however, the lot number was not available and therefore it is not possible to perform a review of the production documentation in order to identify any possible in-process testing failures or quality deviations which may have caused or contributed to a report of this nature.The root cause of the customer¿s experience could not be determined in this instance as no sample was received for investigation.Without a sample to examine it is not possible to determine whether a manufacturing defect could have caused or contributed to a report of this nature.In this instance, without the complaint sample to examine it has not been possible to conclusively link this feedback to a specific failure mode; however, 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 set in the past 12 months.
Event or Problem Description
It was reported that bd maxzero multi-fuse pressure rated extension set with needleless connector was occluded.The following information was received by the initial reporter with the following verbatim: nurses are finding when they administer chemotherapy, which can be a thicker drug, the mx5301 is getting blocked.They had previously been using a baxter healthcare clearlink standard bore 15cm extension set.

• Brand Name: BD MAXZERO MULTI-FUSE PRESSURE RATED 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20218401
• Report Number: 9616066-2024-01309
• Device Sequence Number: 18004769
• Product Code: FPA
• UDI-Device Identifier: 10885403230547
• UDI-Public: (01)10885403230547
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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 Catalogue Number: MZ5301
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown