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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
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used as a default. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: no samples were received for investigation of complaint reported via post market survey; however the customer has indicated that a leakage was identified during use of a bd maxzero¿ needle-free connector. No further information was available to assist the investigation in this instance. The details of this feedback were forwarded to the manufacturing site for investigation. In this instance a lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product. The root cause of the customer¿s experience could not be determined as the sample was not available for investigation. In this instance, without a sample, it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience. In this instance, without the complaint sample or additional information about the exact nature of the defect it is not possible to conclusively link this feedback to a specific failure mode.
 
Event Description
It was reported that 4 bd maxzero¿ needleless connector leaked and 3 were damaged, but still operable. The following information was provided by the initial reporter: "it was reported via post market survey that clinicians encountered leakage of fluids (4) and breaks whilst unscrewing (3). ".
 
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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
MDR Report Key12636235
MDR Text Key276597953
Report Number9616066-2021-52233
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial
Report Date 09/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberMZ1000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2021
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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