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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 ¿ SINGLE PORT 20 GA 1.25 IN; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 20 GA 1.25 IN; INTRAVASCULAR CATHETER Back to Search Results
Model Number 383517
Device Problem Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2022
Event Type  malfunction  
Event Description
It was reported while using bd nexiva¿ closed iv catheter system ¿ single port 20 ga 1.25 in air was drawn into the line.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: the customer reported as follows: after placing this product, the hcp connected a syringe to the catheter adapter, and air was drawn.
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one catheter assembly from a 20gx1.25in nexiva device, lot number 2048021.In addition, four photos were received which displayed similarities to that of the returned unit.Media is observed in the unit which indicates use.A gross visual of the unit identified that the single port luer has been damaged.The damage is a deformation that resulted in a whole on one side of the luer.The unit was then leak tested where air could be heard escaping the luer at the damage area.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to an operator error during a station crash causing the unit to be damaged by the grippers or pallets.Operators performed testing for leakage per the sampling plan.Additionally, pallets are replaced, and maintenance of the line and equipment is performed per the quality plan.The preventative maintenance record was checked and verified to be up to date during the manufacturing of this lot.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
Event Description
It was reported while using bd nexiva¿ closed iv catheter system ¿ single port 20 ga 1.25 in air was drawn into the line.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: the customer reported as follows: after placing this product, the hcp connected a syringe to the catheter adapter, and air was drawn.
 
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Brand Name
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 20 GA 1.25 IN
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 Key16034712
MDR Text Key308370715
Report Number1710034-2022-00849
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
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 02/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number383517
Device Catalogue Number383517
Device Lot Number2048021
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/02/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2022
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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