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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 3-PORT MANIFOLD W/EXT SET INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 3-PORT MANIFOLD W/EXT SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 20519E
Device Problems Leak/Splash (1354); Difficult to Remove (1528); Device Contamination with Chemical or Other Material (2944); Difficult or Delayed Separation (4044)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that 3-port manifold w/ext set was difficult to disconnect lines and had a crack. The following information was provided by the initial reporter: it was reported that the item is difficult to crew and unscrew lines from and sometimes crack. Verbatim: the icu staff has had some concerns and complaints about our current iv manifolds that we have. They have informed me that they are difficult to screw and unscrew lines from and sometimes crack. I would like to change the product we are using.
 
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Brand Name3-PORT MANIFOLD W/EXT SET
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 Key12028502
MDR Text Key257503579
Report Number9616066-2021-51349
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K931173
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 06/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number20519E
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 Received05/24/2021
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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