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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEOFLON YEL 24GA IV CANNULA; INTERVASCULAR NEEDLE

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BECTON DICKINSON MEDICAL (SINGAPORE) NEOFLON YEL 24GA IV CANNULA; INTERVASCULAR NEEDLE Back to Search Results
Catalog Number 391350
Device Problems Difficult to Insert (1316); Failure to Advance (2524); Material Twisted/Bent (2981)
Patient Problem Extravasation (1842)
Event Date 07/15/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 an unspecified number of neoflon yel 24ga iv cannula caused a serious injury to the patient in the form of a change in the course of treatment.The following information was provided by the initial reporter: peelback - needle does not have any visual defects, during the insertion does not want to enter the veins, causing damage, cracks veins.Catheters curl during insertion.
 
Event Description
It was reported that an unspecified number of neoflon yel 24ga iv cannula caused a serious injury to the patient in the form of a change in the course of treatment.The following information was provided by the initial reporter: peelback - needle does not have any visual defects, during the insertion does not want to enter the veins, causing damage, cracks veins.Catheters curl during insertion.
 
Manufacturer Narrative
Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully verify this incident.While we were not able to confirm the report, a trend for the peelback issue has been identified for this product line.As part of the action plan, capa#81917, improvements to the catheter material and the design of the device are in the process of being implemented.The complaint is unconfirmed as no sample is received.No qn or abnormality was observed that could have influenced the issue during dhr review.
 
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Brand Name
NEOFLON YEL 24GA IV CANNULA
Type of Device
INTERVASCULAR NEEDLE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key8850905
MDR Text Key152944911
Report Number8041187-2019-00590
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
N/A
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 08/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2023
Device Catalogue Number391350
Device Lot Number8262011
Initial Date Manufacturer Received 07/15/2019
Initial Date FDA Received08/01/2019
Supplement Dates Manufacturer Received07/15/2019
Supplement Dates FDA Received08/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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