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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 BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD VEO¿ INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE Back to Search Results
Model Number 324906
Device Problem Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/14/2022
Event Type  malfunction  
Event Description
It was reported that 5 bd veo¿ insulin syringes with bd ultra-fine¿ needles experienced product damage while still considered operable.The following information was provided by the initial reporter: consumer reported found the top of syringe to 5 units were melted.Caller drew into syringe humalog and then noticed the outside of barrel to be melted.Caller did not inject with this syringe.
 
Manufacturer Narrative
The date received by manufacturer has been used for this field.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 5 bd veo¿ insulin syringes with bd ultra-fine¿ needles experienced product damage while still considered operable.The following information was provided by the initial reporter: consumer reported found the top of syringe to 5 units were melted.Caller drew into syringe humalog and then noticed the outside of barrel to be melted.Caller did not inject with this syringe.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for evalution?yes,.D10: returned to manufacturer on: 03-jan-2023 h6: investigation summary customer returned two syringes 0.3ml 6mm 90 bx 450 mo.Customer reported that they found the top of syringe to the 5 unit to be melted.Caller drew into syringe humalog and then noticed the outside of barrel to be melted.Caller did not inject with this syringe.However, the syringes were visually inspected.One of the returned syringes was found damaged/scratched on the top the barrel at 5 unit marking.No damages were found on the second returned syringe.A review of the device history record was completed for batch# 1263405.All inspections and challenges were performed per the applicable operations qc specifications.Based on the samples received, embecta was able to confirm the customer¿s indicated failure on one of the returned syringes.Root cause: from the print carousel, the barrels transition to the transfer dial and onto individual guides that carry the barrels through an oven to cure the ink to the barrel.The printed barrels were getting damaged at the transfer dial to the oven guides.H3 other text : see h10.
 
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Brand Name
BD VEO¿ INSULIN SYRINGE WITH 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
8015296192
MDR Report Key15936667
MDR Text Key307889062
Report Number1920898-2022-00859
Device Sequence Number1
Product Code FMF
UDI-Device Identifier50382903249065
UDI-Public00382903249060
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number324906
Device Catalogue Number324906
Device Lot Number1263405
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received02/02/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/20/2021
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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