• 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) 22GX.25MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER SAFETY PORTED CATHETERS

  • 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) 22GX.25MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER SAFETY PORTED CATHETERS Back to Search Results
Catalog Number 393222
Device Problem Mechanical Problem (1384)
Patient Problem Needle Stick/Puncture (2462)
Event Date 05/22/2016
Event Type  Injury  
Manufacturer Narrative
Medical device brand name: 22 g x. 25 mm bd venflon¿ pro safety peripheral safety iv catheter with injection valve. Device evaluation: a sample has been received for evaluation. A supplemental report will be submitted upon completion of the investigation.
 
Event Description
It was reported that the anesthetist inserted the suspect device and when he pulled the needle out, the safety mechanism did not trigger. This resulted in a needle stick injury to the finger from the unprotected needle. The anesthetist followed the facility's needle stick protocol which included lab work. No results were provided but the patient is not known to have an infectious blood disease.
 
Manufacturer Narrative
Device evaluation: result - one actual used sample was received by the manufacturer for evaluation. It was visually observed that the tether foil had detached from the needle protection mechanism. No visual damage was observed. A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 5141276. A maintenance review revealed no abnormality in preventive maintenance and calibration that could have influenced the reported defect. It is suspected that cam guiding plate wear and tear caused the tether to not be properly assembled onto the needle cap. Conclusion - bd was able to confirm the customer's indicated failure mode based on the investigation of the returned sample. A probable root cause for this incident is wear and tear to the cam guiding plate. Non-capa corrective actions have been initiated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name22GX.25MM BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
Type of DeviceSAFETY PORTED CATHETERS
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
8015652845
MDR Report Key5723176
MDR Text Key47334387
Report Number8041187-2016-00041
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2018
Device Catalogue Number393222
Device Lot Number5141276
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/14/2016 Patient Sequence Number: 1
-
-