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

Catalog Number MZ1000 CHINA

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Fda device problem code: 1354.Fda patient problem code: 2199.

Event Description

It was reported that the maxzero needleless connector spontaneously disconnected from the syringe during use.The following information was provided by the initial reporter, translated from chinese to english: "2020-11-20 when using a transparent needleless infusion connector to connect with a syringe without a screw connector or an infusion extension tube, the rebound is fast and they cannot be fixed with infusion connector.".

Manufacturer Narrative

H6: investigation summary: a mz1000 china sample was not available for investigation of this feedback; however the customer indicates that bounceback was identified when attempting to connect the sample to a shuangge luer slip syringe which resulted in leakage of chemotherapy.The connecting product in use at the time of the customer's experience was not returned to assist the investigation.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 19096810 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 in this instance.Without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the reported issue.Please note, in this instance the user facility has opted to use a luer slip syringe therefore the connection to the maxzero valve is a friction fit and relies on the user ensuring that the syringe is securely fitted before use.As stipulated in the user instructions a luer slip syringe should not be left unattended.The directions for use states that ¿if syringe has a luer slip, insert and rotate ¼ turn clockwise to secure connection.Do not leave luer slip unattended¿.H3 other text : see h.10.

Event Description

It was reported that the maxzero needleless connector spontaneously disconnected from the syringe during use.The following information was provided by the initial reporter, translated from chinese to english: "(b)(6) 2020 when using a transparent needleless infusion connector to connect with a syringe without a screw connector or an infusion extension tube, the rebound is fast and they cannot be fixed with infusion connector.".

• Brand Name: 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 22244 ; MX 22244
• MDR Report Key: 11091465
• MDR Text Key: 224795192
• Report Number: 9616066-2020-20674
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

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 Expiration Date: 09/25/2022
• Device Catalogue Number: MZ1000 CHINA
• Device Lot Number: 19096810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1