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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNSPECIFIED BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER
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UNSPECIFIED BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Material Perforation (2205)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2021
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that the needle had pierced through the unspecified bd nexiva¿ closed iv catheter system.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "new nexvia iv catheters in circulation.20g iv in the right ac used for ct of the abdomen with contrast.Per ct tech she was using 1/2 the pressure rate and the contrast was connected to the hub closest to the patient.This has been difficult with the new iv catheters as there is only a single lumen.Pt was positioned as normal, pressure as normal, scan ran as normal.When tubing was checked, the pressure had blown the iv tubing up past where it was clamped.Contrast did not reach the patient.Pt had to be rescanned with contrast, therefore received double the dose of radiation.".
 
Manufacturer Narrative
Investigation: a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record could not be performed as the reported lot was unknown.Our quality engineer reviewed the provided photo and observed that the needle had pierced through the catheter tubing.Therefore, based off the provided photo the engineer was able to verify the reported defect of the needle piercing through the catheter tubing.Unfortunately, without a physical sample a definitive root cause could not be determined.H3 other text.
 
Event Description
It was reported that the needle had pierced through the unspecified bd nexiva¿ closed iv catheter system.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "new nexvia iv catheters in circulation.20g iv in the right ac used for ct of the abdomen with contrast.Per ct tech she was using 1/2 the pressure rate and the contrast was connected to the hub closest to the patient.This has been difficult with the new iv catheters as there is only a single lumen.Pt was positioned as normal, pressure as normal, scan ran as normal.When tubing was checked, the pressure had blown the iv tubing up past where it was clamped.Contrast did not reach the patient.Pt had to be rescanned with contrast, therefore received double the dose of radiation.".
 
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Brand Name
UNSPECIFIED BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Type of Device
INTRAVASCULAR CATHETER
MDR Report Key12125659
MDR Text Key263407580
Report Number2243072-2021-01817
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received08/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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