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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA DUAL PORT WITH Q-SYTE INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA DUAL PORT WITH Q-SYTE INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383536
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2022
Event Type  malfunction  
Event Description
It was reported that an unspecified number of bd nexiva dual port with q-sytes experienced device damage while still considered operable. The following information was provided by the initial reporter: presence of a notch in the needle that prevents removal. After installing the i. V. Catheter i tried to withdraw the needle but the latter remained occluded in the catheter. Complaint noticed: during / after use problem frequency: a few times. Patient injury: no.
 
Manufacturer Narrative
Initial reporter facility name: (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
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Brand NameBD NEXIVA DUAL PORT WITH Q-SYTE
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14830950
MDR Text Key297083554
Report Number1710034-2022-00317
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903835362
UDI-Public00382903835362
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K183399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383536
Device Lot Number1305444
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/02/2021
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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