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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 DUAL PORT CATHETER SYSTEM; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA CLOSED IV DUAL PORT CATHETER SYSTEM; INTRAVASCULAR CATHETER Back to Search Results
Model Number 383531
Device Problem Leak/Splash (1354)
Patient Problem Chemical Exposure (2570)
Event Date 12/17/2020
Event Type  Injury  
Event Description
It was reported that 4 bd nexiva¿ closed iv dual port catheter systems leaked chemotherapy medication onto the patient's skin during use.This complaint was created to capture the 3rd of 4 related incidents.The following information was provided by the initial reporter: "an area around the q-syte was leaking.It caused chemotherapy to leak onto the patients skin which is serious.This is the second such incident that has been reported by the hospital.It has happened 4 times.The first two times it happened the staff in the ward the staff thought it might have been a practice error around tightening the q -syte.".
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval?: yes.D10: returned to manufacturer on: 2/21/2021.H6: investigation: bd received a 24 gauge nexiva closed iv catheter system dual port unit from lot 0139795 for evaluation.A review of the device history record was performed on the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed traces of dried media present in areas through the unit and attached q-syte.There was no visible damage to any of the components of the nexiva catheter unit and its extension line assemblies.Next, a water/air leak test was performed and no leakage was observed coming from the unit.Next, the q-syte units were removed and investigated.A leak test was performed on both units and no leakage was observed.Neither unit appeared to have tears in the column wall.However, there were tears observed in the septum top disk and septum bottom disk for both units.Based off the visual inspection and testing the engineer was unable to verify the reported issue of leakage but could verify the reported issue of damaged septum.A possible root cause for the observed damage was excessive actuations or extraneous force being applied to the q-syte units.
 
Event Description
It was reported that 4 bd nexiva¿ closed iv dual port catheter systems leaked chemotherapy medication onto the patient's skin during use.This complaint was created to capture the 3rd of 4 related incidents.The following information was provided by the initial reporter: "an area around the q-syte was leaking.It caused chemotherapy to leak onto the patients skin which is serious.This is the second such incident that has been reported by the hospital.It has happened 4 times.The first two times it happened the staff in the ward the staff thought it might have been a practice error around tightening the q -syte.".
 
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Brand Name
BD NEXIVA CLOSED IV DUAL PORT 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 Key11181331
MDR Text Key228473328
Report Number1710034-2021-00033
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835318
UDI-Public30382903835318
Combination Product (y/n)N
PMA/PMN Number
K183399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 04/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/30/2023
Device Model Number383531
Device Catalogue Number383531
Device Lot Number0139795
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2021
Date Manufacturer Received04/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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