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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 REMOVABLE PRN 24 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 REMOVABLE PRN 24 GA 0.75 IN INTRAVASCULAR CATHETER Back to Search Results
Model Number 383312
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/10/2022
Event Type  malfunction  
Event Description
It was reported while using bd saf-t-intima¿ safety system with removable prn 24 ga 0. 75 in foreign matter was found in the fluid path. The following information was provided by the initial reporter: the head nurse of the respiratory department of the third affiliated hospital of (b)(6) medicine, (b)(6) hospital reported that on (b)(6) 2022, when preparing for indwelling needle infusion in the ward, when the indwelling needle was disassembled and ready to use, he found that there was mucus at the tip of the catheter, and the nurses in the department also reported that recently many cases of indwelling needle catheters were found to have mucus.
 
Manufacturer Narrative
A sample is available for evaluation. Upon completion of the investigation, a supplemental report will be filed.
 
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Brand NameBD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN 24 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 Key13588510
MDR Text Key286561054
Report Number9610847-2022-00074
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903833123
UDI-Public30382903833123
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K013800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number383312
Device Catalogue Number383312
Device Lot Number1139450
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/03/2021
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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