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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¿ SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN INTRAVASCULAR CATHETER Back to Search Results
Model Number 383323
Device Problem Retraction Problem (1536)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 03/01/2022
Event Type  Injury  
Event Description
It was reported while using bd saf-t-intima¿ safety system with y adapter 22 ga 0. 75 in the needle safety mechanism didn't engage. This led to a dirty needlestick injury. The following information was provided by the initial reporter: it was reported needle retraction failure. (b)(6) 2022. A nurse was stuck with a contaminated needle after this happened when she was activating the safety and the needle came through and stuck her in the finger.
 
Manufacturer Narrative
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 SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13848911
MDR Text Key287619096
Report Number9610847-2022-00112
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903833239
UDI-Public30382903833239
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013800
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 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number383323
Device Catalogue Number383323
Device Lot Number1243091
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/05/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/22/2022 Patient Sequence Number: 1
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