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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. OBTURATOR FOR VENFLON/SAFELON 0.8X25; OBUTRATOR
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. OBTURATOR FOR VENFLON/SAFELON 0.8X25; OBUTRATOR Back to Search Results
Catalog Number 394251
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/05/2021
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 that 2 obturators for venflon/safelon 0.8x25 experienced no label or missing label information.The following information was provided by the initial reporter: we received a complaint from customer that 2 products were missing lot sticker.Upon receiving the products from them (on 09.02.) we checked other products from the same lot and found out, that in one box there were 2 more products with missing stickers, and 3 with stickers applied normally.We had on stock another full box from the same lot but all products were ok.
 
Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the photographs submitted for evaluation.Bd received four photos showing that the dispenser box does not have a label, confirming your reported defect.It was also noted that no sticker residue or damage to the dispenser was present indicating that the dispenser label was most likely not put on the box during the packaging process.This was evidence to support manufacturing/ operator error as the most likely root cause.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
Event Description
It was reported that 2 obturators for venflon/safelon 0.8x25 experienced no label or missing label information.The following information was provided by the initial reporter: we received a complaint from customer that 2 products were missing lot sticker.Upon receiving the products from them (on 09.02.) we checked other products from the same lot and found out, that in one box there were 2 more products with missing stickers, and 3 with stickers applied normally.We had on stock another full box from the same lot but all products were ok.
 
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Brand Name
OBTURATOR FOR VENFLON/SAFELON 0.8X25
Type of Device
OBUTRATOR
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key11457618
MDR Text Key243963900
Report Number1710034-2021-00176
Device Sequence Number1
Product Code FEC
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 04/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/30/2022
Device Catalogue Number394251
Device Lot Number9121585
Was Device Available for Evaluation? No
Date Manufacturer Received04/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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