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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 STRAIGHT CONNECTOR; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD STRAIGHT CONNECTOR; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 1061-000-004
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/11/2022
Event Type  malfunction  
Event Description
It was reported that the bd straight connector experienced mix of product types in a pack.The following information was provided by the initial reporter: the incorrect product a luer lock ring (pictured below) was reviewed and determined not to be of the same design as other luer lock rings within qosina¿s product line.
 
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 straight connector experienced mix of product types in a pack.The following information was provided by the initial reporter: the incorrect product a luer lock ring (pictured below) was reviewed and determined not to be of the same design as other luer lock rings within qosina¿s product line.
 
Manufacturer Narrative
No samples were sent to tj site; however, pictures were sent to tj site to understand the issue reported.By reviewing the pictures, the issue can be identified in the bag of the p/n tc10008229, and the mixed product was confirmed.The problem of mixed product is a condition known to the plant, as there have been reports of this problem with having all oem product packaged in the same area.According with a previous investigation, and in addition with current investigation, it was agreed that the root cause was the lack of racks in the packing area since there was a single rack to have the process material in available generating the risk of mixing.
 
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Brand Name
BD STRAIGHT CONNECTOR
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 Key16112428
MDR Text Key308653280
Report Number9616066-2022-02145
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
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 01/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number1061-000-004
Device Lot Number22015674
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/11/2022
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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