• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383517
Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Packaging Compromised (2916)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/25/2018
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 the bd nexiva¿ closed iv catheter system had ¿a part of the catheter and a part of the needle cover were out of package and sealed. The out parts were cut. ¿ found before use. There was no report of injury or medical intervention.
 
Manufacturer Narrative
Investigation summary: bd received one sample unit for evaluation. It was observed that part of the product popped out of the packaging prior to the sealing process. A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to this observed defect. Level a mdr investigation: dhr review - all challenges and inspections were conducted successfully and no related issues were identified. Qn review - no quality notifications were initiated relating to the defect. Eura review - the cause of the defect was a part out of pocket and the occurrence of this defect does not exceed what is considered acceptable. Visual analysis - the returned sample was inspected and found that the part was in the seal area of the package. The defect was confirmed during the investigation. The part popped out of the pocket prior to the sealing process. Investigation conclusion: the part popped out of the pocket prior to the sealing process. There are two inspection systems to detect part(s) out of pocket prior to sealant of the packages, a physical gate and a visual inspections. However, these inspections are not immediately before the sealing process, which allows a part that pops out of the pocket after the inspections to go undetected. After the sealing process, the packages are then cut and boxed automatically. Manufacturing personnel have been notified of this incident and the findings. The defect rendered the part unusable. The severity and occurrence of this incident does not exceed what is considered acceptable in the eura.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key7278430
MDR Text Key100528770
Report Number1710034-2018-00044
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K161777
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 03/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2020
Device Catalogue Number383517
Device Lot Number7214627
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/16/2018 Patient Sequence Number: 1
-
-