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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 NEXIVA¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383552
Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/28/2018
Event Type  malfunction  
Manufacturer Narrative
Initial reporter occupation other: vascular access support team nurse. 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 bd nexiva¿ closed iv catheter system had a loose plug and leaked. No serious injury or medical intervention was reported.
 
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Brand NameBD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Type of DeviceINTERVASCULAR CATHETER
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 Key7915510
MDR Text Key122007415
Report Number9610847-2018-00314
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835523
UDI-Public30382903835523
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K102520
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2020
Device Catalogue Number383552
Device Lot Number7346995
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 Received09/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2018
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: 09/27/2018 Patient Sequence Number: 1
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