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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 383511
Device Problem Leak/Splash (1354)
Patient Problems Extravasation (1842); Infiltration into Tissue (1931)
Event Date 05/15/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that infiltration/extravasation occurred with a bd nexiva¿ closed iv catheter system.The following information was provided by the initial reporter, "per email: we use your 24 ga 0.75 in 0.7 x 19 mm catheter in our infusion room.Recently we have had several patients infiltrate and i¿m wondering if there possibly could be an issue with the catheter itself.We have used these for several years, and the same person is starting ivs with them.From response email: the catheter infiltrated intravascularly.There was no leakage of blood or body fluid outside of the body." complaint 5 of 5.
 
Manufacturer Narrative
Investigation: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.
 
Event Description
It was reported that infiltration/extravasation occurred with a bd nexiva¿ closed iv catheter system.The following information was provided by the initial reporter, "per email: we use your 24 ga 0.75 in 0.7 x 19 mm catheter in our infusion room.Recently we have had several patients infiltrate and i¿m wondering if there possibly could be an issue with the catheter itself.We have used these for several years, and the same person is starting ivs with them.From response email: the catheter infiltrated intravascularly.There was no leakage of blood or body fluid outside of the body." complaint 5 of 5.
 
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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
MDR Report Key8672616
MDR Text Key147330492
Report Number1710034-2019-00599
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835110
UDI-Public30382903835110
Combination Product (y/n)N
PMA/PMN Number
K183399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 06/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/31/2022
Device Catalogue Number383511
Device Lot Number9053857
Date Manufacturer Received05/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age54 YR
Patient Weight64
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