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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEOFLON PRO SAFETY 24GX0.75IN WINGED INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) NEOFLON PRO SAFETY 24GX0.75IN WINGED INTRAVASCULAR CATHETER Back to Search Results
Model Number 391662
Device Problem Retraction Problem (1536)
Patient Problems Needle Stick/Puncture (2462); Insufficient Information (4580)
Event Date 08/17/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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 neoflon pro safety 24gx0. 75in winged needle would not retract. The following information was provided by the initial reporter: child being cannulated. Registrar removed needle from safety cannula. Needle was difficult to remove and the safety catch failed to deploy leaving needle exposed and causing doctor to sustain needle stick injury.
 
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Brand NameNEOFLON PRO SAFETY 24GX0.75IN WINGED
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12467880
MDR Text Key271278225
Report Number8041187-2021-00835
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K201717
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Model Number391662
Device Catalogue Number391662
Device Lot Number8354798
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/20/2018
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: 09/14/2021 Patient Sequence Number: 1
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