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 PERIPHERAL SAFETY 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 PERIPHERAL SAFETY IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 393229
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 07/09/2019
Event Type  malfunction  
Manufacturer Narrative
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 during use of the bd venflon¿ pro safety peripheral safety iv catheter there was leakage at the injection port of iv fluid and blood.The bd venflon¿ pro safety peripheral safety iv catheter was replaced with a new bd venflon¿ pro safety peripheral safety iv catheter and the leakage stopped.The following information was provided by the initial reporter: patient had 16g venflon in situ throughout surgery, iv fluids running through the venfon.The venflon was patent with no sign of extravasation.Towards the end of the case the venflon injection port was flushed the fluid was still running.At that point it was noticed that the iv fluid and the patients blood was leaking out through the injection port.In very little time this had created a puddle of blood and iv fluid.We stopped the iv fluid and blood continued to escape from the injection port.The anesthetist quickly had to put a new venflon in elsewhere so that we could remove the faulty one as the patient was bleeding out of it.
 
Manufacturer Narrative
Investigation summary: a device history record review was performed and showed no non-conformances associated with this issue during the production of this batch.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
 
Event Description
It was reported that during use of the bd venflon¿ pro safety peripheral safety iv catheter there was leakage at the injection port of iv fluid and blood.The bd venflon¿ pro safety peripheral safety iv catheter was replaced with a new bd venflon¿ pro safety peripheral safety iv catheter and the leakage stopped.The following information was provided by the initial reporter: patient had 16g venflon in situ throughout surgery, iv fluids running through the venfon.The venflon was patent with no sign of extravasation.Towards the end of the case the venflon injection port was flushed the fluid was still running.At that point it was noticed that the iv fluid and the patients blood was leaking out through the injection port.In very little time this had created a puddle of blood and iv fluid.We stopped the iv fluid and blood continued to escape from the injection port.The anesthetist quickly had to put a new venflon in elsewhere so that we could remove the faulty one as the patient was bleeding out of it.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key8839259
MDR Text Key159158603
Report Number8041187-2019-00575
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903932290
UDI-Public382903932290
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 08/12/2019
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 Expiration Date12/31/2021
Device Catalogue Number393229
Device Lot Number8356837
Initial Date Manufacturer Received 07/15/2019
Initial Date FDA Received07/29/2019
Supplement Dates Manufacturer Received07/15/2019
Supplement Dates FDA Received08/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-