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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA TM SINGLE PORT CLOSED IV CANNULA SYSTEM; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA TM SINGLE PORT CLOSED IV CANNULA SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Model Number 383519
Device Problem Retraction Problem (1536)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2022
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd nexiva tm single port closed iv cannula system the needle removal was difficult.There was no report of patient impact.The following information was provided by the initial reporter: this is a report about the difficulty to disengage the needle of nexiva.According to the customer's report, it was difficult to disengage the needle because it was tight.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 14-apr-2022.H.6.Investigation: our quality engineer inspected sample and photographs submitted for evaluation.Bd received one unused 18g x 1.25in.Nexiva unit from lot number 1119152.Additionally, two photos were provided for investigation.A gross visual inspection found that the washer would not move freely, likely indicating that a tolerance issue was present between the needle and washer.This is known to cause resistance when retracting the needle.The unit was functionally tested by attempting to retract the needle.Great resistance was encountered during retraction of the initial segment of the needle.After a small portion of the needle was retracted, the rest of the needle was retracted normally with no resistance.Reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect.Damage to the needle may occur during manufacturing when the needle is manually loaded as well as needle insertion.It may also be raw material related.The incoming material group performs inspections on incoming materials for acceptance criteria.This includes visual inspections and measurements of the needle and washer per the buy specifications.The needle lots involved in the production of this lot were inspection for any related quality notification.No quality notifications were found.Additionally manufacturing performs needle inspections after bumping as well as retraction and functional testing through the process to ensure retraction occurs.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 tm single port closed iv cannula system the needle removal was difficult.There was no report of patient impact.The following information was provided by the initial reporter: this is a report about the difficulty to disengage the needle of nexiva.According to the customer's report, it was difficult to disengage the needle because it was tight.
 
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Brand Name
BD NEXIVA TM SINGLE PORT CLOSED IV CANNULA 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 Key14138343
MDR Text Key289523755
Report Number1710034-2022-00196
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835196
UDI-Public30382903835196
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K102520
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 05/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number383519
Device Catalogue Number383519
Device Lot Number1119152
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2021
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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