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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD VENFLON PRO-SAFETY INSTAFLASH INTRAVASCULAR CATHETER

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BD VENFLON PRO-SAFETY INSTAFLASH INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 393280
Device Problems Retraction Problem (1536); Material Protrusion/Extrusion (2979)
Patient Problems Needle Stick/Puncture (2462); Insufficient Information (4580)
Event Date 09/23/2021
Event Type  Injury  
Manufacturer Narrative
Investigation summary: one photo was received by our quality team for evaluation. The photo shows a top web from batch 0358128 and defect sample where the needle cap is observed to be detached from the tether foil end and the cannula exposed. The tether foil folds on the cannula are correctly formed in a zig-zag fold with no abnormalities. 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. The probable root cause for the safety shield activation failure could be due to the product being bent during needle withdrawal. When the product is bent during use, there is a possibility of overstretching the tether foil and may cause the needle cap safety mechanism to separate and result in an exposed cannula. As no sample was returned and no similar quality notifications were raised in the past 12 months, a root cause could not be determined. This incident has been added to our database of reported incidents.
 
Event Description
It was reported when using the bd venflon pro-safety insta-flash, the device experienced a safety mechanism failure resulting in blood exposure from a used needle. The following information was provided by the initial reporter. The customer stated: the user pricked himself with the catheter because the safety device failed. Unfortunately, the device was not kept.
 
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Brand NameBD VENFLON PRO-SAFETY INSTAFLASH
Type of DeviceINTRAVASCULAR CATHETER
MDR Report Key12674713
MDR Text Key277763706
Report Number8041187-2021-00916
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial
Report Date 09/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number393280
Device Lot Number0358128
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/21/2021 Patient Sequence Number: 1
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