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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 24 GA X 0.56IN SP WITH MAXZERO INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA 24 GA X 0.56IN SP WITH MAXZERO INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383550
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problems Pain (1994); Burning Sensation (2146)
Event Date 06/27/2019
Event Type  malfunction  
Manufacturer Narrative
A sample is available for evaluation. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that during insertion the needle went through the catheter with a bd nexiva 24 ga x 0. 56 in sp with maxzero. The following information was provided by the initial reporter: our pre-procedure nurse inserted a piv on a pt pre procedure in iru. Before she inserted the needle, it didn¿t look like there¿s an issue with it. However, as soon as she inserted it on a patient, the pt complained of burning pain. The nurse decided then to pull out the needle from the patient and noted that the plastic split in half and the actual metal needle is outside the plastic.
 
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Brand NameBD NEXIVA 24 GA X 0.56IN SP WITH MAXZERO
Type of DeviceINTRAVASCULAR 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
8015652341
MDR Report Key8798485
MDR Text Key154554690
Report Number9610847-2019-00468
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Catalogue Number383550
Device Lot Number7327610
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2018
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: 07/17/2019 Patient Sequence Number: 1
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