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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 393224
Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 01/24/2022
Event Type  malfunction  
Event Description
It was reported that blood leaked from a hole in the bd venflon¿ pro safety peripheral safety iv catheter.The following information was provided by the initial reporter: "it" drips out of the hole in the fillet "on venflon.When venflon is placed and you put the white plug on venflon (the one that comes with the set) then the blood runs back and out along the hole.There should usually be a filter stopping it.Have experienced with several items from this lot.".
 
Manufacturer Narrative
Date of event: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to corrected information: h.6.Imdrf annex a grid: a0504 - leak / splash the following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 03-mar-2022.H.6.Investigation: two samples and one photo were received by our quality team for evaluation.From the photo, a 22g venflon pro safety product with blood leakage from the end cap was observed.A representative sample from batch 1140524 was received.The sample was subjected to visual inspection.The sample passed the acceptance criteria, and no abnormalities were observed.The end cap belongs to cavity #21.No hole was observed on the end cap luer cone tip.One used (contaminated) end cap with cavity #49 was also received.The used end cap was subjected to visual inspection.A sink mark was observed on the end cap and a through hole was observed on the luer cone tip.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 end cap batch usage record, for the reported batch 1140524, cavity #49 was not used in the production of this assembled batch.Cavity #49 could be a sample from the same customer of another assembly batch.The probable root cause for the reported leakage could be due to the sink mark hole at the luer cone tip of the end cap.The air vent may be choked during molding and cause hot air to be trapped.This affects the material flow to the final fill area at the luer cone tip.A project, capa#4710247, has been initiated to address this issue.H3 other text : see h.10.
 
Event Description
It was reported that blood leaked from a hole in the bd venflon¿ pro safety peripheral safety iv catheter.The following information was provided by the initial reporter: "it" drips out of the hole in the fillet "on venflon.When venflon is placed and you put the white plug on venflon (the one that comes with the set) then the blood runs back and out along the hole.There should usually be a filter stopping it.Have experienced with several items from this lot.".
 
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Brand Name
BD VENFLON¿ PRO SAFETY PERIPHERAL 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 Key13471931
MDR Text Key286346081
Report Number8041187-2022-00070
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeDA
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,Followup
Report Date 03/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number393224
Device Lot Number1140524
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/25/2021
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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