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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

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BECTON, DICKINSON & CO. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383539
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/30/2018
Event Type  malfunction  
Manufacturer Narrative
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 during use a bd nexiva closed iv catheter system malfunctioned as "the needle broke off." there was no report of exposure, injury or medical intervention needed.
 
Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.
 
Event Description
It was reported that during use a bd nexiva closed iv catheter system malfunctioned as "the needle broke off." there was no report of exposure, injury or medical intervention needed.
 
Manufacturer Narrative
Level b mdr investigation: dhr review - the dhr was reviewed and no issues were identified during production.Qn review - no qns were initiated relating to the defect during production.Eura review - a cause of the defect, that was confirmed during the investigation into other complaints, is a missing feature on the needle.A situation analysis was initiated to further investigate and address the issue.Sample analysis - sample revealed that the needle pulled through the tip shield and that it had no bump.Investigation conclusion: the cause of the defect was a missing feature on the needle that keeps the tip of the needle in the tip shield.A capa initiation determination is being executed to determine the need for a capa.
 
Event Description
It was reported that during use a bd nexiva¿ closed iv catheter system malfunctioned as "the needle broke off." there was no report of exposure, injury or medical intervention needed.
 
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Brand Name
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON, DICKINSON & CO.
150 south 1st avenue
broken bow NE 68822
MDR Report Key7601130
MDR Text Key111491921
Report Number1710034-2018-00351
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835394
UDI-Public30382903835394
Combination Product (y/n)N
PMA/PMN Number
K111366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup,Followup
Report Date 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/28/2021
Device Catalogue Number383539
Device Lot Number8087800
Initial Date Manufacturer Received 05/30/2018
Initial Date FDA Received06/14/2018
Supplement Dates Manufacturer Received05/30/2018
05/30/2018
Supplement Dates FDA Received08/09/2018
09/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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