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U.S. Department of Health and Human Services

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

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BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Model Number 381212
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/30/2021
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.
 
Event Description
It was reported that the bd insyte¿ iv catheter experienced catheter separation from the hub. The following information was provided by the initial reporter: baby had ivc insitu for antibiotics. During routine n/saline flushing, the cannula began to leak. The midwife caring for the baby, removed the tapes and discovered that the plastic cannula had snapped off near the hub. Photos were taken and the length of the cannula was compared to a new cannula to confirm length and ensure no missing parts.
 
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Brand NameBD INSYTE¿ 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12715514
MDR Text Key281915686
Report Number8041187-2021-00936
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K151698
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 11/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number381212
Device Catalogue Number381212
Device Lot Number0224296
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/11/2020
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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