• 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 MEDICAL (SINGAPORE) BD ANGIOCATH PLUS 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 MEDICAL (SINGAPORE) BD ANGIOCATH PLUS IV CATHETER INTERVASCULAR CATHETER Back to Search Results
Catalog Number 382412
Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/15/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 angiocath¿ plus iv catheter experienced a loose needle that was noted during use. The following information was provided by the initial reporter: they said that moving of stylet is too smooth to use. It is dangerous to insertion. Sometimes the cap of catheter open, the stylet has fallen out smoothly.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD ANGIOCATH PLUS IV CATHETER
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10119378
MDR Text Key195783361
Report Number8041187-2020-00323
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number382412
Device Lot Number9298185
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/25/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/04/2020 Patient Sequence Number: 1
-
-