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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383532
Device Problems Disconnection (1171); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/12/2022
Event Type  malfunction  
Event Description
It was reported that the q-syte of the bd nexiva¿ closed iv catheter system separated during use and leaked blood all over the users uniform.The following information was provided by the initial reporter, translated from dutch: "when injecting the system, the qsite of the other t part flies off, leaving you as an introducer completely covered in blood.Normally the qsites on the nexiva needles are tight.This problem causes the caregiver to get covered in blood.Furthermore, you have to go change your uniform because you are covered in blood.The complaint was observed during commissioning of the product; it did not affect the patient.".
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6.Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
Event Description
It was reported that the q-syte of the bd nexiva¿ closed iv catheter system separated during use and leaked blood all over the users uniform.The following information was provided by the initial reporter, translated from dutch: "when injecting the system, the qsite of the other t part flies off, leaving you as an introducer completely covered in blood.Normally the qsites on the nexiva needles are tight.This problem causes the caregiver to get covered in blood.Furthermore, you have to go change your uniform because you are covered in blood.The complaint was observed during commissioning of the product; it did not affect the patient.".
 
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Brand Name
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Type of Device
INTRAVASCULAR 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 Key16118208
MDR Text Key308582654
Report Number1710034-2022-00899
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903835324
UDI-Public00382903835324
Combination Product (y/n)N
Reporter Country CodeNL
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 02/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383532
Device Lot Number2140263
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/16/2022
Initial Date FDA Received01/06/2023
Supplement Dates Manufacturer Received02/07/2023
Supplement Dates FDA Received02/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/20/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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