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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ANGIOCATH PLUS I.V. CATHETER 20GA X 1.16IN INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD ANGIOCATH PLUS I.V. CATHETER 20GA X 1.16IN INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 382437
Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problem No Patient Involvement (2645)
Event Date 05/15/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that bd angiocath plus¿ i. V. Catheter 20ga x 1. 16 in had a loose needle. The following information was provided by the initial reporter: "very smooth moving catheter on the stylet. They said that moving of stylet is too smooth to use. It is dangerous to insertion. Sometimes the cap of catheter open, the stylet has fallen out smoothly. ".
 
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Brand NameBD ANGIOCATH PLUS I.V. CATHETER 20GA X 1.16IN
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 Key10125348
MDR Text Key194616665
Report Number8041187-2020-00326
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeKS
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 07/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number382437
Device Lot Number7139048
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2017
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: 06/05/2020 Patient Sequence Number: 1
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