• 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 INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER 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 INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381044
Device Problems Delivered as Unsterile Product (1421); Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/14/2018
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter had open packaging leading to the sterile barrier being compromised. No serious injury or medical intervention was reported.
 
Event Description
It was reported that bd insyte autoguard bc shielded iv catheter had open packaging leading to the sterile barrier being compromised. No serious injury or medical intervention was reported.
 
Manufacturer Narrative
Our quality engineer inspected the returned units provided by the facility. Bd received two insyte autoguard units from lot number 7019701. The units were received partially open therefore confirming the reported issue. A device history record review showed no non-conformances associated with this issue during the production of this batch. The set-up and in process sample (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak tests were performed on various stages throughout the manufacturing packaging process, all the inspections passed per specifications. The analysis of the top web adhesive where the product characteristics required a specific seal transfer was met per specifications. In addition, the paper top web of the returned units were analyzed under a uv light. The glue used to seal the top and bottom webs was uv fluorescent. This analysis revealed an adequate amount of top web adhesive. The key variables that affected seal strength are seal transfer/width and top web glue. Both variables were looked at during the investigation. The returned unit provided for evaluation for this incident met the manufacturing specification requirements. In conclusion, where the package was found partially opened, the process characteristics that directly influence the seal strength (seal transfer and top web glue), measured within specification. Although the returned unit met specifications, a corrective action project has been implemented to address the issue of inadequate sealing of packages. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business team regularly reviews the collected data for identification of emerging trends.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key7942838
MDR Text Key123689215
Report Number1710034-2018-00699
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K110443
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 10/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2019
Device Catalogue Number381044
Device Lot Number7019701
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/08/2018 Patient Sequence Number: 1
-
-