MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXPLUS¿ NEEDLE-FREE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MP1000 CHINA

Device Problem Leak/Splash (1354)

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

Event Date 08/09/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6).Medical device expiration date: unknown investigation summary: a mp1000 china product was not available for investigation; however the customer confirmed that the complaint sample was from lot 20085930.Further information provided by the customer indicates that the crack occurred following connection to a degao 5ml syringe, and that the component had been swabbed with entoiodine prior to connection.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 20085930 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.Previous investigations have identified that damage of this nature 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 are rare and there is currently no trend for issues of this nature against the mp1000 china product.

Event Description

It was reported that bd maxplus¿ needle-free connector cracked.The following information was provided by the initial reporter: "a crack was found in the joint, which made it impossible to give the patient an infusion.".

• Brand Name: BD MAXPLUS¿ NEEDLE-FREE 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: 12694182
• MDR Text Key: 278359011
• Report Number: 9616066-2021-52303
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K072542
• 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: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MP1000 CHINA
• Device Lot Number: 20085930
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2020
• 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