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 Complete Blockage (1094); Restricted Flow rate (1248)

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

Event Date 09/13/2021

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 12 bd maxzero¿ needleless connectors were blocked and wouldn't drip during their infusions.The following information was provided by the initial reporter, translated from chinese to english: "mz1000 product connector does not drip when connecting indwelling needle, which occurs in geriatrics department.".

Event Description

It was reported that 12 bd maxzero¿ needleless connectors were blocked and wouldn't drip during their infusions.The following information was provided by the initial reporter, translated from chinese to english: "mz1000 product connector does not drip when connecting indwelling needle, which occurs in geriatrics department".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 10/1/2021.H.6.Investigation: two mz1000 china products were received without packaging for investigation.The customer feedback indicates the samples were from lot 20116314.No connecting products were received to assist the investigation.A visual inspection of the returned samples did not identify any product defects or manufacturing issues which could have caused or contributed to the customer's experience.Functional testing was performed by connecting a retained 50ml bd plastipak syringe from stock to the returned samples; in each instance no flow restrictions or occlusions were identified.A definitive root cause could not be identified as testing of the returned samples did not identify any product defects that could have contributed to the customer¿s experience.A review of the production records for lot 20116314 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.H3 other text : see h.10.

• 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: 12609554
• MDR Text Key: 275933801
• Report Number: 9616066-2021-52195
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/21/2023
• Device Catalogue Number: MZ1000 CHINA
• Device Lot Number: 20116314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2020
• 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