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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 LUER ACCESS SPLIT SEPTUM; INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD Q-SYTE LUER ACCESS SPLIT SEPTUM; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 385100
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/30/2023
Event Type  malfunction  
Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported during use of the bd q-syte luer access split septum there were connection issues.The following information was provided by the initial reporter, translated from chinese to english: the connector cannot be tightly connected with the pump tube and infusion tube during use.
 
Event Description
It was reported during use of the bd q-syte luer access split septum there were connection issues.The following information was provided by the initial reporter, translated from chinese to english: the connector cannot be tightly connected with the pump tube and infusion tube during use.
 
Manufacturer Narrative
H6: investigation summary since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
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Brand Name
BD Q-SYTE LUER ACCESS SPLIT SEPTUM
Type of Device
INTRAVASCULAR ADMINISTRATION SET
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
phillip emmert
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17200358
MDR Text Key318242463
Report Number1710034-2023-00728
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,Followup
Report Date 07/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number385100
Device Catalogue Number385100
Device Lot Number2118470
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/02/2023
Initial Date FDA Received06/26/2023
Supplement Dates Manufacturer Received07/17/2023
Supplement Dates FDA Received08/07/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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