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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 STAND-ALONE LUER ACCESS SPLIT SEPTUM

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE LUER ACCESS SPLIT SEPTUM Back to Search Results
Catalog Number 385100
Device Problems Detachment Of Device Component (1104); Structural Problem (2506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/21/2018
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. 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 there were concerns when using bd q-syte¿ luer access split-septum stand-alone devices as they reportedly "disconnect between the q syte luers and iv giving sets. " there was no report of exposure, serious injury or medical intervention.
 
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Brand NameBD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE
Type of DeviceLUER ACCESS SPLIT SEPTUM
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7516142
MDR Text Key108493509
Report Number9610847-2018-00126
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00382903851003
UDI-Public00382903851003
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K013621
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number385100
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/15/2018 Patient Sequence Number: 1
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