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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV CATHETER 18GA 1.88IN INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV CATHETER 18GA 1.88IN INTRAVASCULAR CATHETER Back to Search Results
Model Number 381247
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/05/2021
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.
 
Event Description
It was reported that bd insyte¿ iv catheter 18ga 1. 88in contained foreign matter. The following information was provided by the initial reporter: "during preoperative venipecesis at 9:00, unknown foreign matter was found in the indwelling needle head. ".
 
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Brand NameBD INSYTE¿ IV CATHETER 18GA 1.88IN
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 Key12624413
MDR Text Key276666775
Report Number8041187-2021-00897
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903812470
UDI-Public30382903812470
Combination Product (y/n)N
Reporter Country CodeCH
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 10/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number381247
Device Catalogue Number381247
Device Lot Number0325537
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2020
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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