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U.S. Department of Health and Human Services

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

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXZERO NEEDLELESS CONNECTOR INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number MZ1000-07
Device Problems Complete Blockage (1094); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/29/2021
Event Type  malfunction  
Manufacturer Narrative
Medical 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 the bd maxzero¿ needleless connector tubing was occluded, and burst from the pressure of lipids backing up into the morphine syringe during the tpn drip. The following information was provided by the initial reporter: "bottom line is our tiny baby, had some significant issues with picc line occlusion overnight. It took us forever to trouble shoot, change various portions of tubing and filters. The line itself was totally fine. It was newly placed the night before, had tpn running with a ms drip, 1. 4fr picc. When i disconnected a new max zero clave from the ha, it kind of exploded with back pressure. In the hours we had been trouble shooting, thinking her fluids were restarting for periods of time, i think it had been backing up that whole time, because her glucose was 15. I connected the ha directly to the picc for a period of time, to get her some dextrose, and we basically started over with new tubing, and ended up holding the lipids for the rest of the night without further issue. The reason we blamed the lipids were that they were also backing up all the way into the morphine syringe, but the lipids themselves never alarmed. I wasn¿t sure what else to do. The picu said they are having issues with backing up as well, but mostly with the tri fuse for some reason. This baby did have a trifuse, and we changed that as well and ultimately traded it for 2 bifuses, but that isn¿t a long term solution either. I guess we will see with this baby today when lipids are restarted. ".
 
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Brand NameBD MAXZERO 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
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 Key12533280
MDR Text Key273557087
Report Number9616066-2021-52128
Device Sequence Number1
Product Code FPA
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
Report Date 09/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberMZ1000-07
Device Lot NumberUNKNOWN
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 Received08/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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