MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXZERO NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MZ1000

Device Problems Backflow (1064); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 09/26/2023

Event Type  malfunction  

Event Description

It was reported that the bd maxzero needleless connector experienced backflow causing leakage.The following information was provided by the initial reporter: venous return with blood leakage customer flags that during use the product caused venous return with blood leakage.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

No additional information it was reported that the bd maxzero needleless connector experienced backflow causing leakage.The following information was provided by the initial reporter: venous return with blood leakage customer flags that during use the product caused venous return with blood leakage.

Manufacturer Narrative

Investigation results: one hundred and ninety mz1000 samples from lot 22115508 were received in sealed packaging for investigation.The customer reported that the product caused "venous return with blood leakage".They also stated that the event occurred during priming and no physical cracks were observed on the affected sample.Ten of the returned samples were functionally tested by priming and flushing with a 50ml bd plastipak syringe from stock and no defects or abnormalities were observed.Moreover, the components were then subjected to pressure testing, again no leakage was observed throughout testing.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 22115508 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.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.Please note the maxzero is not a back check valve and under certain circumstances it is possible for blood to back flow into the maxzero; such a phenomenon can occur if the patient has high blood pressure.As stated in the directions for use "flush the maxzero after each use with normal saline or in accordance with facility protocol." and "failure to properly prime the device can result in reflux".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 this is a rare occurrence with a small number of similar reports against the mz1000 product in the past 12 months.

• Brand Name: BD MAXZERO 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17924782
• MDR Text Key: 325532420
• Report Number: 9616066-2023-02065
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403224782
• UDI-Public: (01)10885403224782
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

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
• Device Operator: Other
• Device Catalogue Number: MZ1000
• Device Lot Number: 22115508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 12/15/2023
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2022
• 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