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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER; INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 393222
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/15/2021
Event Type  malfunction  
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 when using the bd venflon¿ pro safety shielded iv catheter, the device experienced the catheter breaking and separating from the hub.The following information was provided by the initial reporter.The customer stated: difficulty placing the catheter.When the nurse tried to remove it, the silicone protector (cathlon) had come out of the mandrel.
 
Event Description
It was reported when using the bd venflon¿ pro safety shielded iv catheter, the device experienced the catheter breaking and separating from the hub.The following information was provided by the initial reporter.The customer stated: difficulty placing the catheter.When the nurse tried to remove it, the silicone protector (cathlon) had come out of the mandrel.
 
Manufacturer Narrative
H6: investigation summary one sample was received by our quality team for evaluation.The sample was subjected to visual inspection.Blood is seen at the catheter and flow control plug.Needle pierced through the catheter was observed on the returned sample.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.Based on the returned sample, blood was observed in the flow control plug.This indicates a successful penetration.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 pierced through the catheter and damaged the catheter.However, as it is not possible to confirm how the product has been used, the root cause cannot be determined.H3 other text : see h10.
 
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Brand Name
BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR ADMINISTRATION SET
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 Key12818094
MDR Text Key280825654
Report Number8041187-2021-00978
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
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 12/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2024
Device Catalogue Number393222
Device Lot Number1076673
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/18/2021
Initial Date FDA Received11/16/2021
Supplement Dates Manufacturer Received11/30/2021
Supplement Dates FDA Received12/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/05/2021
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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