• 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 STOPCOCK 3 WAY WITH 10CM EXTENTION TUBING INTRAVASCULAR ADMINISTRATION SET

  • 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 STOPCOCK 3 WAY WITH 10CM EXTENTION TUBING INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 394995
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/02/2022
Event Type  malfunction  
Event Description
It was reported while using bd stopcock 3 way with 10cm extention tubing the tubing expanded. There was no report of patient impact. The following information was provided by the initial reporter: swelling of the connector during injection of the contrast medium. Injection at 2cc/s on an implantable chamber.
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete. Upon completion, a supplemental report will be filed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD STOPCOCK 3 WAY WITH 10CM EXTENTION TUBING
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
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 Key14940161
MDR Text Key303245890
Report Number9610847-2022-00250
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
NA
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 09/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number394995
Device Lot Number2005355
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/28/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-