Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 BLOOD CONTROL TECHNOLOGY; 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 BLOOD CONTROL TECHNOLOGY; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 382523
Device Problem Degraded (1153)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/11/2022
Event Type  malfunction  
Event Description
It was reported while using a bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology the catheter tip was damaged.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that when the health professional opened the angiocath the white plastic tip was severed.
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary: the reported defect could not be refuted nor confirmed in the absence of a sample.A device history record review showed no non-conformances associated with this issue during the production of this batch.The root cause cannot be determined for an unconfirmed defect.
 
Event Description
It was reported while using a bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology the catheter tip was damaged.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that when the health professional opened the angiocath the white plastic tip was severed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15470236
MDR Text Key305792194
Report Number1710034-2022-00529
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903825233
UDI-Public00382903825233
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number382523
Device Lot Number2056518
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/07/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-