Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXZERO NEEDLELESS CONNECTOR EXPERIENCED LEAKAGE.; INTRAVASCULAR ADMINISTRATION SET
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXZERO NEEDLELESS CONNECTOR EXPERIENCED LEAKAGE.; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number MZ1000-07
Device Problem Leak/Splash (1354)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/05/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that at least one bd maxzero needleless connector experienced leakage.The following information was provided by the initial reporter: medication syringe leaked during administration at the site of the syringe luer lock tip.Upon preliminary investigation, it is determined that certain bd 3 ml syringes will consistently result in leakage during administration.
 
Event Description
It was reported that at least one bd maxzero needleless connector experienced leakage.The following information was provided by the initial reporter: medication syringe leaked during administration at the site of the syringe luer lock tip.Upon preliminary investigation, it is determined that certain bd 3 ml syringes will consistently result in leakage during administration.
 
Manufacturer Narrative
H6: investigation summary : the customer reported leakage with a maxzero and 3 ml syringe, and returned the two samples connected.The maxzero and 3 ml syringe leaked when connected and the complaint was verified.The manufacturing plant for the syringe conducted further investigation and verified syringe was causing the leak.A technical report was generated to challenge the failure modes in the mold temperature and the injection process.Updates to the quality check of molded syringes include a leak test with the help of the maxzero device.These actions along with a prior funded project to address the issue are in place to reduce the risk of this failure recurring.A device history record review for model mz1000-07 lot number 21125410 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 09dec2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h10.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD MAXZERO NEEDLELESS CONNECTOR EXPERIENCED LEAKAGE.
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 Key14461416
MDR Text Key292348149
Report Number9616066-2022-00643
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403230196
UDI-Public10885403230196
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMZ1000-07
Device Catalogue NumberMZ1000-07
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/23/2022
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 Number1
-
-