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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA¿ SAFETY IV CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA¿ SAFETY IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Model Number 386862
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2022
Event Type  malfunction  
Event Description
It was reported that foreign matter/extra material was found on the bd cathena¿ safety iv catheter.The following information was provided by the initial reporter: extra material on the end of a 20 g iv catheter.It appeared to be plastic string material.
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
 
Event Description
It was reported that foreign matter/extra material was found on the bd cathena¿ safety iv catheter.The following information was provided by the initial reporter: extra material on the end of a 20 g iv catheter.It appeared to be plastic string material.
 
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Brand Name
BD CATHENA¿ SAFETY IV CATHETER
Type of Device
INTRAVASCULAR 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14828246
MDR Text Key303239897
Report Number8041187-2022-00332
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903868629
UDI-Public00382903868629
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201717
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number386862
Device Catalogue Number386862
Device Lot Number1358415
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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