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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
Model Number 383539
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2022
Event Type  malfunction  
Event Description
It was reported bd nexiva¿ closed iv catheter system had leakage issues.The following information was provided by the initial reporter: ".Catheter is placed, presenting a leak in the fin and stabilization with union to a passive biosafety device.".
 
Manufacturer Narrative
Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the photographs submitted for evaluation.Bd received three photos which displayed a used 18ga bd nexiva closed iv catheter dual port system unit.The device consists of the catheter adapter and extension line assemblies with one q-syte at the end of one of the luer adapters.The pinch clamp is disengaged and there are traces of media present throughout the unit.There are arrows pointing at the area of the canister in two of the photos.Media between the canister and the clear port of the winged adapter and the customer verbatim the leakage was occurring at beyond the septum at the canister, suggests leakage beyond the septum.Through the visual observation of the photos, it is revealed that the primary septum is not in the correct position.The septum shows to be caught between the canister and the inner wall of the clear port of the winged adapter and drug up on the side of the canister.The reported issue was confirmed.This was the physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to a misalignment or damaged/worn tooling when the septum is to be seated.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.
 
Event Description
It was reported bd nexiva¿ closed iv catheter system had leakage issues.The following information was provided by the initial reporter: ".Catheter is placed, presenting a leak in the fin and stabilization with union to a passive biosafety device.".
 
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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
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 Key13640229
MDR Text Key286742374
Report Number1710034-2022-00100
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835394
UDI-Public30382903835394
Combination Product (y/n)N
Reporter Country CodeMX
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 03/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number383539
Device Catalogue Number383539
Device Lot Number1119156
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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
Patient Age52 YR
Patient SexFemale
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