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

Catalog Number MZ1000 CHINA

Device Problem Leak/Splash (1354)

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

Event Date 09/14/2021

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.

Event Description

It was reported that the bd maxzero¿ needleless connector iv set separated from the syringe and caused liquid to leak out.The following information was provided by the initial reporter, translated from (b)(6) to english: "the nurse gave the patient an intravenous injection of chemotherapeutic drugs, and connected the transparent needle-free connector to the syringe.The syringe was ejected directly because the interface was not tightly anastomosed, which caused the liquid to leak and wasted.At the same time, it is easy to cause nurses¿ occupational exposure and the patient is not satisfied." adr# (b)(4).

Manufacturer Narrative

H.6.Investigation: a mz1000 china product was not available for investigation; however the customer confirmed that the complaint sample was from lot: 20125201.The connecting product in use at the time of the customer's experience was not returned to assist the investigation.Further information provided by the customer confirmed that the disconnection occurred when the maxzero was connected to a lelun 5ml syringe.The details of this feedback were forwarded to the manufacturing site for investigation.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.A review of the production records for lot: 20125201 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.

Event Description

It was reported that the bd maxzero¿ needleless connector iv set separated from the syringe and caused liquid to leak out.The following information was provided by the initial reporter, translated from chinese to english: "the nurse gave the patient an intravenous injection of chemotherapeutic drugs, and connected the transparent needle-free connector to the syringe.The syringe was ejected directly because the interface was not tightly anastomosed, which caused the liquid to leak and wasted.At the same time, it is easy to cause nurses¿ occupational exposure and the patient is not satisfied." adr#: (b)(4).

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12636962
• MDR Text Key: 276599659
• Report Number: 9616066-2021-52238
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

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: Health Professional
• Device Expiration Date: 12/17/2023
• Device Catalogue Number: MZ1000 CHINA
• Device Lot Number: 20125201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 10/25/2021
• Supplement Dates FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2020
• 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