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 MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY 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 MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 393222
Device Problems Retraction Problem (1536); Material Protrusion/Extrusion (2979)
Patient Problem Needle Stick/Puncture (2462)
Event Date 12/02/2021
Event Type  Injury  
Event Description
It was reported that the bd venflon¿ pro safety shielded iv catheter safety shield did not fully cover the needle after use, resulting in a dirty needle stick.The affected nurse had blood testing done and a month of antiretroviral medication prescribed as a result.The following information was provided by the initial reporter: "yesterday, one of your venflon 22g did not encapsulate the needle.This resulted in a needle stick injury, having the affected nurse to be prescribed with a course of antiretroviral medication for a month.
 
Manufacturer Narrative
Investigation summary: one photo was received by our quality team for evaluation.From the photo, a tether foil is observed to be detached from the needle cap and the needle is exposed.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the returned photo, the probable root cause could be due to the product being bent during withdrawal causing the tether foil end to be stretched and detached from the needle cap heat stake post.However, as the actual sample was not returned, further investigation cannot be performed.Therefore, the root cause cannot be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
 
Manufacturer Narrative
The following fields have been updated due to corrected information: h.6.Imdrf annex a grid: a0510 retraction problem.The previous entry of a0411 should be considered void.
 
Event Description
It was reported that the bd venflon¿ pro safety shielded iv catheter safety shield did not fully cover the needle after use, resulting in a dirty needle stick.The affected nurse had blood testing done and a month of antiretroviral medication prescribed as a result.The following information was provided by the initial reporter: "yesterday, one of your venflon 22g did not encapsulate the needle.This resulted in a needle stick injury, having the affected nurse to be prescribed with a course of antiretroviral medication for a month.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13122379
MDR Text Key285559201
Report Number8041187-2021-01084
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number393222
Device Lot Number1202339
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/03/2021
Initial Date FDA Received12/30/2021
Supplement Dates Manufacturer Received01/28/2022
Supplement Dates FDA Received02/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-