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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO; INTERVASCULAR CATHETER
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BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO; INTERVASCULAR CATHETER Back to Search Results
Catalog Number 393204
Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2021
Event Type  malfunction  
Event Description
It was reported that the bd venflon¿ pro experienced a needle through the catheter during catheter introduction.The following information was provided by the initial reporter: in the case of the last delivery (in september) some of vps catheters (20g) are inserted without any problems, and in the case of some, they are rolled up and delaminated.The procedures in hospital have not changed and the nurses are very experienced.
 
Manufacturer Narrative
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 the bd venflon¿ pro experienced a needle through the catheter during catheter introduction.The following information was provided by the initial reporter: in the case of the last delivery (in september) some of vps catheters (20g) are inserted without any problems, and in the case of some, they are rolled up and delaminated.The procedures in hospital have not changed and the nurses are very experienced.
 
Manufacturer Narrative
The following field was updated due to corrected information: h.6.Imdrf annex a grid: a041001 material puncture/hole.H.6.Investigation: one photo of a used sample was received by our quality team for evaluation.From the photo, blood was observed in the catheter and the flow control plug.The needle pierced through the catheter was also observed.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.There is a 100% online automated vision inspection system that can detect and reject product not meeting the lie distance requirement.If the needle pierced through the catheter in the manufacturing process, the defective part would be rejected by the automated vision inspection system as the product will not have any lie distance.As blood was observed in the catheter and flow control plug, a successful penetration is indicated.It would not be possible to penetrate the vein if the needle was pierced through the catheter.Therefore, the probable root cause for the reported defect could be due to the user having partially withdrawing the needle from the catheter and upon reinserting the needle into the vein, the needle pieced through and damaged the catheter.H3 other text : see h.10.
 
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Brand Name
BD VENFLON¿ PRO
Type of Device
INTERVASCULAR 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 Key12708263
MDR Text Key284210638
Report Number8041187-2021-00932
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodePL
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 12/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2023
Device Catalogue Number393204
Device Lot Number0081833
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/08/2020
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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