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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. Q-SYTE CLOSED LUER ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. Q-SYTE CLOSED LUER ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 385100
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2021
Event Type  malfunction  
Manufacturer Narrative
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 that q-syte closed luer access device had foreign matter. The following information was provided by the initial reporter: black foreign body in q-syte connector was found during pre-use inspection.
 
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Brand NameQ-SYTE CLOSED LUER ACCESS DEVICE
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
MDR Report Key12339298
MDR Text Key267169415
Report Number9610847-2021-00377
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00382903851003
UDI-Public00382903851003
Combination Product (y/n)N
PMA/PMN Number
K013621
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 09/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number385100
Device Lot Number0088543
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2020
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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