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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO SAFETY 14GA 2.0MM OD 45MM L; INTRAVASCULAR CATHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO SAFETY 14GA 2.0MM OD 45MM L; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 393230
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem Needle Stick/Puncture (2462)
Event Date 08/20/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that venflon pro safety 14ga 2.0mm od 45mm l was missing the shield cover.The following information was provided by the initial reporter: "last week there was a needle stick injury with the accompanying needle.Unfortunately, i have not yet been able to speak to the relevant employee about this, however the report indicates that it is presumably a factory error.The security sleeve was not on.Fortunately, this has not had any unpleasant consequences for her, but it seems to me that it makes sense for the supplier to be aware of this so that they can check whether there are possibly several needles in circulation without a protective sleeve.Can you deal with the relevant supplier or would you like to provide us with the contact details of the relevant supplier so that we can contact you? thanks in advance! the needle in question has been preserved.".
 
Event Description
It was reported that venflon pro safety 14ga 2.0mm od 45mm l was missing the shield cover.The following information was provided by the initial reporter: "last week there was a needle stick injury with the accompanying needle.Unfortunately, i have not yet been able to speak to the relevant employee about this, however the report indicates that it is presumably a factory error.The security sleeve was not on.Fortunately, this has not had any unpleasant consequences for her, but it seems to me that it makes sense for the supplier to be aware of this so that they can check whether there are possibly several needles in circulation without a protective sleeve.Can you deal with the relevant supplier or would you like to provide us with the contact details of the relevant supplier so that we can contact you? thanks in advance! the needle in question has been preserved.".
 
Manufacturer Narrative
The following field was updated due to corrected information: h.1.Type of reportable events: serious injury.H.6.Investigation: one photo was received by our quality team for evaluation.The photo shows the top web of the packaging and one used sample.The sample was observed with the needle safety mechanism was not fully activated and the needle is exposed and not contained within the needle cap.Therefore, the team is able to confirm the customer experience based on the photo returned.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.
 
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Brand Name
VENFLON PRO SAFETY 14GA 2.0MM OD 45MM L
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key10525647
MDR Text Key207924293
Report Number8041187-2020-00564
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,Followup
Report Date 09/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2022
Device Catalogue Number393230
Device Lot Number9080800
Was Device Available for Evaluation? No
Date Manufacturer Received08/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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