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

Model Number MZ1000-07

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one mz1000 sample was received for investigation without packaging; however the customer feedback confirmed the lot number.A visual inspection of the returned maxzero identified a crack on the female luer adaptor of the component; functional testing confirmed the customer's experience as leakage was observed from the crack.The details of this feedback were forwarded to the manufacturing site for investigation.They performed an in-depth investigation in order to determine a potential root cause for damage of this nature; during the investigation no obvious manufacturing defects or potential manufacturing contributors were identified which may have resulted in the observed damage.A review of the production records did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Although a definitive root cause could not be determined in this instance, previous investigations have confirmed similar damage can be caused or contributed to by a combination of different factors, including prolonged use of substances that are aggressive to plastics, over-torque of the component during connection with the male luer, or use of a male luer that is not compliant to iso standards.In this instance based on the information available, it is not possible to determine which of these factors may have contributed to the customer's experience.A review of the customer feedback database indicates that complaints of this nature against the maxzero product occur at a low frequency and have not been attributable to a product defect or manufacturing issue.

Event Description

It was reported bd maxzero needleless connector was damaged, resulting in leakage.The following information was provided by the initial reporter, translated from (b)(6) : ".Leakage was observed, and a crack on the female luer was then confirmed.".

• 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
• MDR Report Key: 12724292
• MDR Text Key: 279301115
• Report Number: 9616066-2021-52334
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403230194
• UDI-Public: 50885403230194
• Combination Product (y/n): N
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/12/2024
• Device Model Number: MZ1000-07
• Device Catalogue Number: MZ1000
• Device Lot Number: 21015540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Date Manufacturer Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2021
• 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