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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ 18 GA X 1.75 IN HF SINGLE PORT; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ 18 GA X 1.75 IN HF SINGLE PORT; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383520
Device Problems Leak/Splash (1354); Free or Unrestricted Flow (2945)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/20/2019
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 after needle is removed blood leaks at the septum and air bubbles are occurring with a bd nexiva¿ 18 ga x 1.75 in hf single port.The following information was provided by the initial reporter, translated from german to english: we are still satisfied with the nexiva, but there have now been 2x incidents at the nexiva plants.After the needle has been removed, blood runs through the gray septum.Also, when purging the pvk, the rinse liquid will run across the gray septum.
 
Manufacturer Narrative
Investigation summary: received 2 nexiva 18ga units as follows: unit 1: received a used catheter-adapter extension set with a miscellaneous connector on it single port.Unit 2: received a full assembly within a sealed package from lot 8166590.All components were intact.A review of the device history record revealed no irregularities during the manufacture of the reported lot.Unit 1: visual examination: the unit was received heavily soiled with patient residue (blood).Evidence of leakage (blood stains) was observed between the canister and the adapter port.It was not possible to determine the septum position/condition due to blood presence.Water-leak test: ¿the water-leak test results were indeterminate since the air could not flow through the blockage caused by the hardened blood on the ext.Tubing and below the wedge.¿the unit was left soaking on bleach-water solution as an attempt to clean out the blockage.The attempt failed, the blood could not be removed.Note: the septum assembly was dissected from the rest of the assembly.Microscopic examination: ¿the septum was not properly seated (assembled) into the canister.Unit 2: visual examination: ¿no physical-mechanical damage was observed on any of the components of the unused unit received.¿the septum-canister assembly was properly seated and in place water-leak test: ¿no leakage was observed during the performance of the water-leak test.Conclusion(s): unit 1 ¿ manufacturing ¿ although a definite source that caused the defect found on the septum-canister assembly (miss-assembled) and which would cause the unit to leak or ¿air in line¿ could not be determined, the failure was manufacturing related note: product quality is evaluated during the manufacturing process with prescribed variable and attributes inspections.These inspections are performed by operators to ensure process changes are identified.If defects are observed, disposition of the product, root cause and corrective action are applied according to the quality control plan.This plan includes challenge samples for ¿septum presence¿ ¿septum not fully seated¿ and ¿septum position¿.Unit 2 ¿ indeterminate ¿ the returned representative unit did not display any adverse characteristics that would contribute to the defect the customer experienced, and the failure described in the event description could not be replicated at the laboratory.
 
Event Description
It was reported that after needle is removed blood leaks at the septum and air bubbles are occurring with a bd nexiva¿ 18 ga x 1.75 in hf single port.The following information was provided by the initial reporter, translated from german to english: we are still satisfied with the nexiva, but there have now been 2x incidents at the nexiva plants.After the needle has been removed, blood runs through the gray septum.Also, when purging the pvk, the rinse liquid will run across the gray septum.
 
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Brand Name
BD NEXIVA¿ 18 GA X 1.75 IN HF SINGLE PORT
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key8888996
MDR Text Key156501521
Report Number1710034-2019-00879
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835202
UDI-Public30382903835202
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 09/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2021
Device Catalogue Number383520
Device Lot Number8166590
Date Manufacturer Received07/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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