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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-N¿ IV CATHETER 24GA 0.56IN INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-N¿ IV CATHETER 24GA 0.56IN INTRAVASCULAR CATHETER Back to Search Results
Model Number 381211
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/07/2021
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that 2 bd insyte-n¿ iv catheters 24ga 0. 56in experienced a needle that pierced through the needle cover. The following information was provided by the initial reporter: nurses and registrar noted on preparing for iv cannular insertion, bd insyte-n 24 ga 14mm, that the needles were going through the side of the plastic sleeve, also one we opened had a right angle bend at its tip. Registrar went to insert iv cannular into 3month old baby, but the guiding needle had gone out the side of plastic sleeve (part that is left in vein) this prickled skin but could not be advanced so failed and had to re-cannulate.
 
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Brand NameBD INSYTE-N¿ IV CATHETER 24GA 0.56IN
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key12316669
MDR Text Key266411396
Report Number8041187-2021-00719
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K151698
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 09/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number381211
Device Catalogue Number381211
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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