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U.S. Department of Health and Human Services

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

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MAXZERO NEEDLELESS CONNECTOR INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number MZ1000-07
Device Problem Leak/Splash (1354)
Patient Problem Not Applicable (3189)
Event Date 01/13/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Investigation summary: no product or photo was returned by the customer. The customer complaint of leaking blood could not be verified due to the product not being returned for failure investigation. A device history record review for model mz1000-07 lot number 20096909 was performed. The search showed that a total of 76,803 units in 1 lot number was built on 23sep2020. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. The root cause of this failure could not be identified without a failure investigation. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the maxzero needleless connector leaked drops of blood from the lumen during use. Blood cultures were drawn and tested for infection and cbc, and the needless connector was replaced. The following information was provided by the initial reporter: "patient called rn after returning to bed from using the bathroom. Noticed lumen of central venous access device leaking small drops of blood. Needleless connector disconnected from lumen. Nurse notified md, drew blood cultures to assess for infection and cbc to assess for change in blood counts. Needless connector replaced. ".
 
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Brand NameMAXZERO NEEDLELESS CONNECTOR
Type of DeviceINTRAVASCULAR 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
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana 22244
MX 22244
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11274750
MDR Text Key233318235
Report Number9616066-2021-50160
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K132413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMZ1000-07
Device Catalogue NumberMZ1000-07
Device Lot Number20096909
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/03/2021 Patient Sequence Number: 1
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