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

Catalog Number MZ1000-07

Device Problem Leak/Splash (1354)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/04/2022

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd maxzero needleless connector experienced leakage.The following information was provided by the initial reporter: medication syringes leaked during administration at the site of the syringe luer-lok tip.It was determined that certain bd 3 ml syringes will consistently result in leakage during administration.

Manufacturer Narrative

H6: investigation summary: the customer reported leakage with a maxzero and 3 ml syringe, and returned the two samples connected.The maxzero and 3 ml syringe leaked when connected and the complaint was verified.The manufacturing plant for the syringe conducted further investigation and verified the leak as coming from the syringe and not the maxzero.A technical report was generated to challenge the failure modes in the mold temperature and the injection process.Updates to the quality check of molded syringes include a leak test with the help of the maxzero device.These actions along with a prior funded project to address the issue are in place to reduce the risk of this failure recurring.A device history review could not be completed as no batch number was provided.H3 other text : see h10.

Event Description

It was reported that the bd maxzero needleless connector experienced leakage.The following information was provided by the initial reporter: medication syringes leaked during administration at the site of the syringe luer-lok tip.It was determined that certain bd 3 ml syringes will consistently result in leakage during administration.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14477929
• MDR Text Key: 292508139
• Report Number: 9616066-2022-00658
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MZ1000-07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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