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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE Back to Search Results
Model Number 324910
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2023
Event Type  malfunction  
Event Description
It was reported that silicone in the insulin vial was drawn into the bd veo¿ insulin syringe with the bd ultra-fine¿ needle during use.The following information was provided by the initial reporter: "consumer reported finding syringes placed into her novolog and levimer to place silicone in her sons insulin vials.She sent the vials back to novo for evaluation.And was informed this is common from novo.But not harmful.".
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Manufacturer Narrative
H6: investigation summary no samples including photos were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to the batch being unknown, no dhr review can be completed.H3 other text : see h10.
 
Event Description
It was reported that silicone in the insulin vial was drawn into the bd veo¿ insulin syringe with the bd ultra-fine¿ needle during use.The following information was provided by the initial reporter: "consumer reported finding syringes placed into her novolog and levimer to place silicone in her sons insulin vials.She sent the vials back to novo for evaluation.And was informed this is common from novo.But not harmful.".
 
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Brand Name
BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer (Section G)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key16527211
MDR Text Key311255453
Report Number1920898-2023-00114
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903249107
UDI-Public00382903249107
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K212499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number324910
Device Catalogue Number324910
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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