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

Catalog Number MZ1000 CHINA

Device Problems Fracture (1260); Leak/Splash (1354)

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

Event Date 04/12/2022

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 6 bd maxzero¿ needleless connectors were damaged, resulting in leakage.The following information was provided by the initial reporter: "when the connector was connected to the pump for infusion of drugs for 2-3 days, it was found that the screw shell was vertically ruptured and fluid leakage occurred".

Event Description

It was reported 6 bd maxzero¿ needleless connectors were damaged, resulting in leakage.The following information was provided by the initial reporter: "when the connector was connected to the pump for infusion of drugs for 2-3 days, it was found that the screw shell was vertically ruptured and fluid leakage occurred".

Manufacturer Narrative

H6: investigation summary a mz1000 china product was not available for investigation; however the customer confirmed that the complaint sample was from lot 21085878.As part of the investigation, the customer provided a photograph of the affected sample; analysis of the photograph identified that a crack was present at the female luer adaptor of the product.The details of this feedback were forwarded to the manufacturing site for investigation.Previous investigations have been unable to determine a potential root cause for the customer's experience; no obvious manufacturing defects or potential manufacturing contributors were identified which may have resulted in the observed damage.A review of the production records for lot 21085878 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.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14306428
• MDR Text Key: 290930972
• Report Number: 9616066-2022-00527
• 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: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MZ1000 CHINA
• Device Lot Number: 21085878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2021
• 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