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

Model Number MZ1000-07

Device Problem Leak/Splash (1354)

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

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown investigation summary: one mz1000 sample from an unknown lot was received for investigation without packaging; no connecting product was returned to assist the investigation.Further information provided by the customer indicates that the leakage was observed during infusion.A visual inspection of the returned maxzero identified a crack on the female luer adaptor (fla) 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 cracks of this nature; during the investigation no obvious manufacturing defects or potential manufacturing contributors were identified which may have resulted in the observed damage.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.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.

Event Description

It was reported two bd maxzero¿ needle-free connectors had issues with leakage.The following information was provided by the initial reporter, translated from (b)(4): "it leaked from max zero in the infusion.".

• Brand Name: BD MAXZERO¿ NEEDLE-FREE CONNECTORS
• 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: 12667489
• MDR Text Key: 277676377
• Report Number: 9616066-2021-52266
• 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: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MZ1000-07
• Device Catalogue Number: MZ1000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Date Manufacturer Received: 09/22/2021
• 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