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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD Q-SYTE; SET, ADMINISTRATION, INTRAVASCULAR
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD Q-SYTE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 385100
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2024
Event Type  malfunction  
Event Description
It was reported that the bd q-syte leaked.The following information was provided by the intial reporter translated from chinese to english: "normal use of infusion connector connected to the indwelling needle infusion, afterward infusion check found infusion connector at the leakage, stop using timely replacement.".
 
Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
 
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Brand Name
BD Q-SYTE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key18993663
MDR Text Key339139830
Report Number1710034-2024-00253
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00382903851003
UDI-Public(01)00382903851003
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K013621
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number385100
Device Lot Number2346125
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/07/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/27/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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