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	MZ9279
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
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 extension set with needleless connector had a valve malfunction.The following information was received by the initial reporter with the following verbatim: pt has a premicath 28g 1 lumen picc with 2 x 2way extension sets with back check valves attached.The second 2-way extension set with back check valves had a lipid medication (white in colour) running through 1 lumen and the other lumen was idle at the time with nothing attached to the mz1000 bung and unclamped (intermittent medications being given but not at the time of event).The lipid was noted to be backtracking up the idle line and past the back check valve.I've attached a photo.Confirmed with the clinician that the lipid had never been attached to the other lumen.
Additional Manufacturer Narrative
Additional information: details added to b5 from customer initial reporter phone number investigation results: two mz9297 samples were received without packaging for investigation.It was received with white residual throughout, connected to each other and a 1.2 um filter.The customer reported that they experienced backflow from the bcv from the lot #23099433.The returned samples were subjected to functional testing by priming and subjecting to an infusion using a 50ml bd plastipak syringe after clearing the system of any residual white fluid and no issue was observed; furthermore, when back pressure was applied at male luer as well as occluding the male luer and attempting to flush from one smartsite to the other side, no backflow was observed at any of the bcv, the details of this feedback were forwarded to the manufacturing site for investigation.In this instance, a definitive root cause could not be identified as testing of the returned samples did not identify any product defects or quality deviation that could have contributed to the customer¿s experience.A review of the production records for lot #23099433 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Although it was not possible to determine a definite root cause for this issue, the quality team at the manufacturing site has been informed of this complaint in order to be aware of the reported failure mode during future production of this product.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 mz9279 product.
Event or Problem Description
Additional information: the make model of the connections are bd fn-02-lds filter above the back check valve.Above that is a dedicated agila iv set ¿ unknown code number.They use agila infusion pumps with the pressure limit set at 200 (this hadn¿t been activated/alarmed however) , however as per this pir the back check valve that the lipid went past did not have a pump attached as it was an idle line.The surrounding lines had agila pumps infusing.I have sent an email to kanta with the infusions and rates for this one ¿ as per below: the tpn was running through the first 2 way ext set at 8.7ml and the smof was running at 1.42ml on the second 2 way extension set.The line that had lipid past the bcv (2nd 2 way ext set) was a caffeine infusion that had run through the night before and turned off (and not clamped).There was no visible damage to any of the sets other than lipid going past the back check valve on inspection.It was during infusion, not during priming.

• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19028609
• Report Number: 9616066-2024-00513
• Device Sequence Number: 8035740
• Product Code: FPA
• UDI-Device Identifier: 10885403230622
• UDI-Public: (01)10885403230622
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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: 09/28/2026
• Device Catalogue Number: MZ9279
• Device Lot Number: 23099433
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown