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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H10 INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H10 INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383556
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 12/02/2020
Event Type  malfunction  
Manufacturer Narrative
Medical device brand name: bd nexiva¿ closed iv catheter system ¿ single port with maxzero¿ needleless connector 20 ga 1. 00 in. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that the bd nexiva¿ closed iv catheter system ¿ single port with maxzero¿ needleless connector 20 ga 1. 00 in experienced a catheter that broke/separated from the hub. The following information was provided by the initial reporter: complaint 1 of 6. Material no: 383556, batch no: 0014645. On (b)(6) 2020 - catheter broke/separated before placement. When prepping nexiva iv catheter for an iv start, the gray connector device disconnected from the iv catheter as a whole. This piece is not supposed to disconnect until after the iv has been started and the catheter has been threaded through.
 
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Brand NameSEE H10
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11101028
MDR Text Key224588793
Report Number1710034-2020-00846
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00382903835560
UDI-Public00382903835560
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 other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383556
Device Lot Number0014645
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2020
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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