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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L CATHETER Back to Search Results
Catalog Number 393224
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/09/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device lot #: the customer provided lot # 0229500p02. This does not match the catalog number provided. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that venflon pro safety 20ga 1. 1mm od 32mm l hub separated. The following information was provided by the initial reporter: during the insertion of the cvp, after punching the vein, the metallic spindle of the cvp retracted itself. The retraction of the mandrel has carried the cannula with it as if the mandrel were not detached from the cannula. At the time of the spindle removal part of the cannula broke remaining in the forearm of the patient, part that was removed with surgical forceps.
 
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Brand NameVENFLON PRO SAFETY 20GA 1.1MM OD 32MM L
Type of DeviceCATHETER
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11712675
MDR Text Key264711674
Report Number8041187-2021-00338
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIT
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 06/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number393224
Device Lot NumberUNKNOWN
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 Received06/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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