• Decrease font size
  • Return font size to normal
  • Increase font size
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 24 GA 0.75 IN INTRAVASCULAR CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 24 GA 0.75 IN INTRAVASCULAR CATHETER Back to Search Results
Model Number 383313
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/27/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field. A device evaluation and/or device history review is anticipated but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd saf-t-intima¿ safety system with y adapter 24 ga 0. 75 in a loose needle was discovered. The following information was provided by the initial reporter: the catheter came with the needle bent and loose (rotating). Was the reported incident noticed before, during, or after use on the patient? before. Was there any harm to the patient/healthcare provider? (detail) no.
 
Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field. A device evaluation and/or device history review is anticipated but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd saf-t-intima¿ safety system with y adapter 24 ga 0. 75 in a loose needle was discovered. The following information was provided by the initial reporter: the catheter came with the needle bent and loose (rotating). Was the reported incident noticed before, during, or after use on the patient? before. Was there any harm to the patient/healthcare provider? (detail) no.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 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 Key13295755
MDR Text Key285768489
Report Number9610847-2022-00010
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903833130
UDI-Public30382903833130
Combination Product (y/n)N
Reporter Country CodeBR
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 05/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number383313
Device Catalogue Number383313
Device Lot Number1053927
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/16/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-