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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; INTRAVASCULAR CATHETER
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BECTON DICKINSON VENFLON I 20GA 1.0 MM X 32MM; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 391592
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 10/17/2020
Event Type  malfunction  
Manufacturer Narrative
The manufacturing location for this product is (b)(4).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that 1000 venflon pro 18 g catheters were found in the box of venflon i 20ga 1.0 mm x 32mm catheters.The following information was provided by the initial reporter: "1000 units venflon pro 18 g supplied in sealed box of venflon i 20 g.It should have contained venflon i 20 g only.".
 
Event Description
It was reported that 1000 venflon pro 18 g catheters were found in the box of venflon i 20ga 1.0 mm x 32mm catheters.The following information was provided by the initial reporter: "1000 units venflon pro 18 g supplied in sealed box of venflon i 20 g.It should have contained venflon i 20 g only.".
 
Manufacturer Narrative
H.6.Investigation: a photo was received by bd for evaluation.A quality engineer was able to review the photo of a 1cc safetyglide syringe from lot # 0118542, regarding item # 391592 with the reported issue that, ¿1000 units venflon pro 18 g supplied in sealed box of venflon i 20 g.It should have contained venflon i 20 g only¿.The photograph showed the evidence of product mix (venflon pro in venflon i 20ga).Customer returned sample is not available for investigation.Upon further investigation of the two lot numbers that got mixed and their dhr review the investigating team found that both the lot numbers have been produced and released from the plant with a gap of 12 days.This rules out the probability of the product getting mixed during packaging.The team reviewed the photographs of the product mix and found that the outside carton had the label of venflon i 20 ga while the shipper had venflon pro 18ga sticker on the boxes.The defect is confirmed.The probable product mix has occurred outside the plant.H3 other text : see h.10.
 
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Brand Name
VENFLON I 20GA 1.0 MM X 32MM
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key10827161
MDR Text Key217167199
Report Number2243072-2020-01811
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 distributor,foreign,other
Type of Report Initial,Followup
Report Date 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number391592
Device Lot Number0118542
Was Device Available for Evaluation? No
Date Manufacturer Received12/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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