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

Device Problem Failure to Disconnect (2541)

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

Event Date 08/01/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a mz5301 sample was not available for investigation; however, the customer indicated the complaint samples were from lots 21095727 and 21095723.The feedback provided by the customer indicates the male luer of the extension set is difficult to disconnect from an unknown catheter; furthermore the customer indicates a change in design of the male luer.As part of the investigation the customer provided a photograph of the complaint sample, analysis of this photograph does indicate the design of the male luer of the mz5301 is different in comparison to an older product model; however, a visual inspection did not identify any product defects or manufacturing issues which could have caused or 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 lots 21095727 and 21095723 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.However, the manufacturing site confirmed that the mz5301 product previously could be manufactured with either design of male luer, however all future production of the mz5301 product will be manufactured with the luer design where the collar can not be slid down the length of the tubing.Please note the affected product was manufactured in (b)(6) 2021, prior to the corrective action being implemented on the (b)(6) 2021.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 mz5301 product in the past 12 months.H3 other text : see section h10.

Event Description

It was reported that the bd maxzero¿ multi-fuse pressure rated extension set with needleless connector male luer got stuck on the catheter, and an instrument was needed to disconnect it.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "luer lock connector gets stuck on the cvk.Need instrument to disconnect mz5301.Customer sees a difference from older products and experiences difference for the worse.[.] the product's luer connection can be passed backwards on the tube.The customer thinks there is a risk of decontamination and a risk of sepsis.[.]the customers are very concerned regarding the new spin luers on the maxzero extensions because they can very easily be removed back on the tubing and eventually be stucked so they have to use a peang to get it off.[.] the customers are very concerned the new spin luers on the maxzero extensions because they very easily can be removed back on the tubing.This has earlier (2014) caused some serious incidents (icn330920) where the extension has been stucked into the catheter and has not been able to be removed.The luer was changed shortly after that due to the high risk.But now customer noticed the same type of is spin luer and the same type of problem again.This luer-connection is very concerning due to very high risk of making mistake when trying to disconnect the extension and worst case breaking the male piston in the female connector.[.]".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15316969
• MDR Text Key: 305539110
• Report Number: 9616066-2022-01239
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230547
• UDI-Public: 10885403230547
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MZ5301
• Device Lot Number: 21095723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1