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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE

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BD MEDICAL - DIABETES CARE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE Back to Search Results
Model Number 324911
Device Problems Component Missing (2306); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/31/2023
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.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 the bd veo¿ insulin syringes with bd ultra-fine¿ needle was damaged.The following information was provided by the initial reporter: syringe plunger deformed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 24-feb-2023.Investigation summary: the customer returned two 0.5ml 31ga syringes reporting that there was an issue with the syringes, one of the plungers was deformed and the second one was missing the needle.The syringes were visually inspected.Upon visual inspection, embecta was able to confirm that the needle hub separates from the barrel.Manufacturing (holdrege) will be notified of the observed issue.A review of the device history record was completed for batch# 2103775.All inspections and challenges were performed per the applicable operations qc specifications.Embecta was able to duplicate or confirm the customer¿s indicated failure of needle hub separates from the barrel.A definitive root cause cannot be determined.
 
Event Description
It was reported that the bd veo¿ insulin syringes with bd ultra-fine¿ needle was damaged.The following information was provided by the initial reporter: syringe plunger deformed.
 
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Brand Name
BD VEO¿ INSULIN SYRINGES 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
8448235433
MDR Report Key16441326
MDR Text Key310254886
Report Number1920898-2023-00069
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903249114
UDI-Public(01)00382903249114
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190054
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 03/16/2023
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 Model Number324911
Device Catalogue Number324911
Device Lot Number2103775
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/31/2023
Initial Date FDA Received02/26/2023
Supplement Dates Manufacturer Received03/16/2023
Supplement Dates FDA Received03/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/13/2022
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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