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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L; CATHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L; CATHETER Back to Search Results
Catalog Number 393224
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)
Event Date 10/04/2021
Event Type  malfunction  
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.
 
Event Description
It was reported that venflon pro safety 20ga 1.1mm od 32mm l catheter broke.The following information was provided by the initial reporter: problems with iv, burr and elevations in cannula (catheter).Pieces come loose in the blood vessel, this is very dangerous.
 
Event Description
It was reported that venflon pro safety 20ga 1.1mm od 32mm l catheter broke.The following information was provided by the initial reporter: problems with iv, burr and elevations in cannula (catheter).Pieces come loose in the blood vessel, this is very dangerous.
 
Manufacturer Narrative
H6: investigation: two photos, nine representative samples, and five used samples were received by our quality team for evaluation.The representative samples were subjected to visual inspection and no abnormalities were observed.One used sample and catheter lube from the machine was sent for fourier transform infrared spectroscopy (ftir) analysis.Based results, the gel-like substances are similar and found to be silicone compound from catheter lube.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 manufacturing process was reviewed.In the catheter lubrication station, the assembled product would be dipped into high viscosity silicone lube.Excess lube on the catheter surface would then be removed at the vacuum station.The probable root cause for the reported condition of this complaint could be due to accumulation of catheter lube around the vacuum station holder.The accumulated catheter lube could have been in contact with the surface of the product catheter during the vacuum process step to remove excess catheter lube.This can cause residue of an accumulated catheter lube to be attached to the product catheter surface resulting in the gel-like substance on the catheter surface.The other probable cause could be due to the vacuum station with clogged with excess lube and hence unable to effectively removed the excess lube from the product catheter after lubrication.
 
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Brand Name
VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L
Type of Device
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12738335
MDR Text Key279647059
Report Number8041187-2021-00941
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeNL
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 11/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number393224
Device Lot Number1175160
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2021
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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