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U.S. Department of Health and Human Services

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

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BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE VIALON-E IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 388434
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Date 10/13/2020
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 bd insyte¿ vialon-e iv catheter packaging had a hole in it. The following information was provided by the initial reporter, translated from (b)(6) to english: "the correct issue was "packages have a hole which may be caused by needle pierced through packages". ".
 
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Brand NameBD INSYTE VIALON-E IV 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 Key10793149
MDR Text Key216414668
Report Number8041187-2020-00712
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
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 12/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number388434
Device Lot Number9024657
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2019
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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