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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 ALARIS SMARTSITE EXTENSION SET INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS SMARTSITE EXTENSION SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 20027E
Device Problems Leak/Splash (1354); Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/23/2021
Event Type  malfunction  
Event Description
It was reported that the bd alaris smartsite extension set experienced component separation. The following information was provided by the initial reporter: a filter (bd smartsite extension set 0. 2 micron low protein binding filter) was placed in the tpn line as per policy. While priming that line, the filter popped off the line severing the line and leaking tpn onto the work surface. Tpn was clamped and the line was redone in a sterile fashion.
 
Manufacturer Narrative
Medical device expiration date: na. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
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Brand NameBD ALARIS SMARTSITE EXTENSION 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 Key12919972
MDR Text Key284987552
Report Number9616066-2021-52527
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960280
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 03/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20027E
Device Catalogue Number20027E
Device Lot Number20129528
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2020
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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