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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE IV WINGED CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE IV WINGED CATHETER INTRAVASCULAR CATHETER Back to Search Results
Model Number 381312
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 11/11/2020
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. (b)(4).
 
Event Description
It was reported that the front end of the bd insyte¿ iv winged catheter was damaged. The following information was provided by the initial reporter, translated from (b)(6) to english: "when the nurse punctures the indwelling needle for the patient and opens the package of indwelling needle, she finds that the front end of the catheter tube is rough with barbs and cannot be used, so she shall immediately replace the new indwelling needle".
 
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Brand NameBD INSYTE IV WINGED 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
8015296192
MDR Report Key11033045
MDR Text Key224821867
Report Number8041187-2020-00847
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903813125
UDI-Public30382903813125
Combination Product (y/n)N
Reporter Country CodeCH
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
Report Date 12/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number381312
Device Catalogue Number381312
Device Lot Number9081606
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 Received11/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2019
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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