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U.S. Department of Health and Human Services

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

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BECTON DICKINSON MEDICAL (SINGAPORE) BD NEOFLON¿ PRO IV CANNULA INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 391389
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/24/2022
Event Type  malfunction  
Manufacturer Narrative
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. Examination of the product involved may provide clarification as to the cause for the reported failure. Complaints received for this product and condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that while using a bd neoflon¿ pro iv cannula, the catheter was damaged. The following information was provided by the initial reporter: catheter damage during the insertion in pre-term babies.
 
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Brand NameBD NEOFLON¿ PRO IV CANNULA
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15090049
MDR Text Key302966165
Report Number8041187-2022-00393
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
NA
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
Report Date 07/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number391389
Device Lot Number1295240
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2021
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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