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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 Q-SYTE LUER ACCESS SPLIT SEPTUM INTRAVASCULAR ADMINISTRATION SET

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE LUER ACCESS SPLIT SEPTUM INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 385100
Device Problems Leak/Splash (1354); Free or Unrestricted Flow (2945)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter zip:(b)(6). 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 bd q-syte luer access split septum had a leak in the luer lock, causing air in the line. The following information was provided by the initial reporter: "patient¿s vas/cath assess noted inadequate seal between syringe and q-site, creating micro bubbles in syringe, q-site changed problem resolved. ".
 
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Brand NameBD Q-SYTE LUER ACCESS SPLIT SEPTUM
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12550283
MDR Text Key274746226
Report Number1710034-2021-00850
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeAS
PMA/PMN Number
K013621
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2021
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 Number1118491
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/17/2021
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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