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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 NEEDLE-FREE VALVE; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS SMARTSITE NEEDLE-FREE VALVE; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2000E
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2022
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the bd alaris smartsite needle-free valve had damaged packaging that resulted in breached sterility.The following information was provided by the initial reporter: packaging damaged when it arrived.Stated that the individual devices/packaging of devices were damaged.
 
Manufacturer Narrative
H.6.Investigation summary: a complaint of packaging coming damaged was received from the customer.Two boxes were returned for investigation.Through visual inspection, the customer complaint was confirmed.The packaging was bent and damaged.A device history record review for model 2000e lot number 22065389 was performed.The search showed that a total of (b)(4) in 1 lot number were built on 06jun2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of this defect.The root cause for this defect was determined to be issues during shipping and transporting.
 
Event Description
It was reported that the bd alaris smartsite needle-free valve had damaged packaging that resulted in breached sterility.The following information was provided by the initial reporter: packaging damaged when it arrived.Stated that the individual devices/packaging of devices were damaged.
 
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Brand Name
BD ALARIS SMARTSITE NEEDLE-FREE VALVE
Type of Device
INTRAVASCULAR 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15303203
MDR Text Key305254159
Report Number9616066-2022-01233
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203011938
UDI-Public07613203011938
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 08/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2000E
Device Catalogue Number2000E
Device Lot Number22065389
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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