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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 383532
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2021
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 2 bd nexiva¿ closed iv catheter system had reported of foreign matter.The following information was provided by the initial reporter, translated from (b)(6): "access port discoloration".
 
Manufacturer Narrative
H6: investigation summary : our quality engineer inspected the samples and photographs submitted for evaluation.Bd received two unopened units and four photographs for investigation.Through the visual/microscopic evaluation the septum of the q-sytes displayed a yellow tint or discoloration.There were no other anomalies or damage observed with the q-syte unit.The reported issue was confirmed.Although the reported issue was confirmed, we are unable to determine an exact root cause.Discoloration of the q-syte septum may be raw material related; however, no quality issues were found for the inspections of the raw material lots used in the q-syte production.During the q-syte manufacturing process discoloration of the septum may occur during the adhesive curing process if the part remains in the oven beyond a set time.There is an automated rejection set for the parts that are left in the oven beyond prescribed time period.Quality records have been consulted for tracking and trending purposes and this was the first occurrence of this failure mode.Sterilization of the device is not commonly associated with discoloration of the septum however there is a small likelihood that discoloration may occur.No quality issues or process deviations were found.During handling/storage of the product discoloration may occur.The storage conditions of the product may have resulted in discoloring of the septum as revealed by the possible uv light discoloration during manufacturing.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.A device history record was reviewed.
 
Event Description
It was reported 2 bd nexiva¿ closed iv catheter system had reported of foreign matter.The following information was provided by the initial reporter, translated from japanese: "access port discoloration".
 
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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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12788719
MDR Text Key280601871
Report Number1710034-2021-00971
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903835325
UDI-Public30382903835325
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K183399
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 11/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2021
Device Model Number383532
Device Catalogue Number383532
Device Lot Number8325685
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/13/2021
Initial Date FDA Received11/10/2021
Supplement Dates Manufacturer Received11/12/2021
Supplement Dates FDA Received12/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2018
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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