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 MZ5303

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd maxzero multi-fuse pressure rated extension set with needleless connector was loose the following information was received by the initial reporter with the following verbatim: this is a complaint about loose connection.Dull "connection feeling" when connecting female side (mixed pouring part) with other manufacturer's product.When the customer connected the extension to the peripheral route to make sure there was no looseness, there was no complete disconnection, but there was a feeling that it was not firmly connected until the very end.

Manufacturer Narrative

Investigation results: one mz5303 sample was received in opened packaging from lot 23089350 for investigation.No residual fluid was present in the returned sample, and no connecting device was returned to aid the investigation.The customer reported that there's a "feeling of loose connecting" when connecting the maxzero to an unknown extension set.A visual inspection of the returned sample did not identify any product defects or manufacturing issues which could have caused or contributed to the customer's experience.Functional testing confirmed the connection between the maxzero and other bd stock products remained secure; no inadvertent disconnection occurred throughout testing despite attempts at manipulation.Furthermore, no leakage was observed from any part of the infusion set throughout pressure testing.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 sample 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 23089350 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 definitive root cause for the customers experience, 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 this is a rare occurrence with this customer being the only customer to provide this type of feedback against the mz5303 set in the past 12 months.

Event Description

Additional information: please confirm what substance was being infused during the time of the event? the event occurred prior to the administration of the drug solution, so nothing was administered.Please confirm when the fault was identified during priming or during infusion? if during infusion, how long into the infusion? during "test connection" before use.

• Brand Name: BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR
• Type of Device: 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: 18976299
• MDR Text Key: 338735345
• Report Number: 9616066-2024-00471
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230561
• UDI-Public: (01)10885403230561
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MZ5303
• Device Lot Number: 23089350
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1