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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Model Number 383322
Device Problem Material Protrusion/Extrusion (2979)
Patient Problems Inflammation (1932); Local Reaction (2035); Sepsis (2067); Skin Inflammation (2443)
Event Date 12/21/2020
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. (b)(4).
 
Event Description
It was reported that the bd saf-t-intima¿ iv catheter safety system safety mechanism did not engage correctly over the needle during use. The following information was provided by the initial reporter: "safety mechanism did not engage correctly during deployment of the safe-t-intima as a subcutaneous device, the plastic covering did not engage over the end of the needle. No injury was incurred, and the device was able to be used for medication delivery".
 
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Brand NameBD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11175493
MDR Text Key227039475
Report Number9610847-2021-00015
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K013800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number383322
Device Catalogue Number383322
Device Lot Number9224839
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2019
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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