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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE PERIPHERAL VENOUS CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE PERIPHERAL VENOUS CATHETER INTRAVASCULAR CATHETER Back to Search Results
Model Number 381237
Device Problem Delivered as Unsterile Product (1421)
Patient Problem Aspiration/Inhalation (1725)
Event Date 09/22/2020
Event Type  Injury  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Fda device problem code: 1421, fda patient problem code: 1745.
 
Event Description
It was reported that the bd insyte¿ peripheral venous catheter needle pierced through the shield after use on a vdrl patient, resulting in a dirty needle stick injury. The user followed-up with the opd. The following information was provided by the initial reporter: "got needle stick injury re-capture the needle,it passes through the top of the cap, causing needle stick injury" "the patient had vdrl" "user opd follow up".
 
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Brand NameBD INSYTE PERIPHERAL VENOUS CATHETER
Type of DeviceINTRAVASCULAR 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 Key10668532
MDR Text Key211259574
Report Number8041187-2020-00670
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K151698
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 10/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number381237
Device Catalogue Number381237
Device Lot Number9298167
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 Received09/22/2020
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: 10/13/2020 Patient Sequence Number: 1
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