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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON VENFLON I 20GA 1.0 MM X 32MM; CATHETER
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BECTON DICKINSON VENFLON I 20GA 1.0 MM X 32MM; CATHETER Back to Search Results
Catalog Number 391592
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 01/28/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).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 i 20ga 1.0 mm x 32mm catheter tip was damaged.This occurred on 5 occasions.The following information was provided by the initial reporter: catheter tip damaged found in venflon i 20g.
 
Event Description
It was reported that venflon i 20ga 1.0 mm x 32mm catheter tip was damaged.This occurred on 5 occasions.The following information was provided by the initial reporter: catheter tip damaged found in venflon i 20g.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/2/2021.H.6.Investigation: the samples were received by bd for evaluation.A quality engineer was able to review the returned (5) venflon 1 20ga from lot # 0210959 product # 391592 with the reported issue of ¿catheter tip damaged¿.The dhr was reviewed and no ncp or qn was raised on this lot during manufacturing and production of the lot number 0210959 until lot release.Customer returned samples and photograph are available for investigation.The team has investigated the samples and found the defect to be present on one of the samples.The defect is confirmed.The cannula tip was found to be bent and unevenly cut on one of the samples in the customer return samples.The investigating team has analyzed the complete process of the manufacturing on the machine and concluded that the probable root cause of the tip damage may have occurred during the process of reloading on va 35.Reloading of the components that fall off the conveyor are reloaded manually.This defect could be a one of case caused by human error due to manual intervention.
 
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Brand Name
VENFLON I 20GA 1.0 MM X 32MM
Type of Device
CATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11372071
MDR Text Key233285242
Report Number2243072-2021-00589
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 03/03/2021
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 Other
Device Catalogue Number391592
Device Lot Number0210959
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2021
Initial Date Manufacturer Received 01/28/2021
Initial Date FDA Received02/24/2021
Supplement Dates Manufacturer Received03/03/2021
Supplement Dates FDA Received03/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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