• 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¿ 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¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381433
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/21/2019
Event Type  Injury  
Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter separated from the hub during use, and the broken piece had to be surgically removed from the patient's arm.The following information was provided by the initial reporter: "when dcing an iv, the cathlon separated from the hub and had to be surgically removed from the patient's arm.".
 
Manufacturer Narrative
Investigation summary: received one specimen container with the catheter tubing inside.The catheter tubing has been used and contains dried media and the original packaging was not returned with the sample.A dhr review was not performed as the lot number is "unknown" for this complaint.Upon comparison with a representative sample from the lab.It was determined that the sample received was not a product from bd sandy.The tubing produced at bd sandy has vialon (clear) and radiopaque (white) stripes which are not present in the received sample.Absence of the stripes tells us that the product was not manufactured at bd sandy.Conclusion(s): not determined: the probably root cause could not be determined as the sample was not manufactured at bd sandy.
 
Event Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter separated from the hub during use and the broken piece had to be surgically removed from the patients arm.The following information was provided by the initial reporter: "when dcing an iv, the cathlon separated from the hub and had to be surgically removed from the patients arm.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key9296194
MDR Text Key165604709
Report Number1710034-2019-01196
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903814337
UDI-Public30382903814337
Combination Product (y/n)N
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 12/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381433
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2019
Date Manufacturer Received10/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-