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; INTERVASCULAR 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; INTERVASCULAR CATHETER Back to Search Results
Catalog Number 382644
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Fda device problem code(s): (b)(4).Fda patient problem code(s): (b)(4).
 
Event Description
It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter experienced leakage.The following information was provided by the initial reporter: material no: 382644 batch no: 0164703 started 18g iv on pt, after flushing line it started leaking, tried changing tubing but line continued to leak, nurse decided to remove iv and found that the iv catheter was leaking next to the wing of the catheter.
 
Manufacturer Narrative
Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.
 
Event Description
It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter experienced leakage.The following information was provided by the initial reporter: material no: 382644 batch no: 0164703 started 18g iv on pt, after flushing line it started leaking, tried changing tubing but line continued to leak, nurse decided to remove iv and found that the iv catheter was leaking next to the wing of the catheter.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER
Type of Device
INTERVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key11103490
MDR Text Key225795909
Report Number1710034-2020-00852
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903826445
UDI-Public00382903826445
Combination Product (y/n)N
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 01/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2023
Device Catalogue Number382644
Device Lot Number0164703
Was Device Available for Evaluation? No
Date Manufacturer Received01/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-