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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
Catalog Number 324909
Device Problems Complete Blockage (1094); Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.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 bd veo¿ insulin syringes with bd ultra-fine¿ needles were unable to aspirate and had a deformed stopper.The following information was provided by the initial reporter : the consumer reported the needle not drawing and the rubber stopper slanted in the barrel.Date of event : unknown.Samples : available.
 
Manufacturer Narrative
Date of event: unknown.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 bd veo¿ insulin syringes with bd ultra-fine¿ needles were unable to aspirate and had a deformed stopper.The following information was provided by the initial reporter : the consumer reported the needle not drawing and the rubber stopper slanted in the barrel.Date of event : unknown.Samples : available.
 
Event Description
It was reported that 2 bd veo¿ insulin syringes with bd ultra-fine¿ needles were unable to aspirate and had a deformed stopper.The following information was provided by the initial reporter : the consumer reported the needle not drawing and the rubber stopper slanted in the barrel.Date of event : unknown.Samples : available.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2022-02-16.H6: investigation summary customer returned a single 0.3ml, 31 gauge, 6mm syringe from lot 1102431.Visual inspection of the syringe found that the rubber stopper was dragging and warped.While the syringe was technically capable of drawing liquid, it was noted that the rubber stopper dragged inside the syringe barrel, making this process more difficult than intended.A review of the device history record was completed for batch# 1102431.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the sample received, bd was able to confirm the customer¿s indicated failure of stopper damage.Root cause for this defect cannot be determined.H3 other text : see h10.
 
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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
8015296192
MDR Report Key13499689
MDR Text Key285499724
Report Number1920898-2022-00087
Device Sequence Number1
Product Code FMF
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/09/2022
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 Lay User/Patient
Device Catalogue Number324909
Device Lot Number1102431
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/26/2022
Initial Date FDA Received02/09/2022
Supplement Dates Manufacturer Received03/09/2022
Supplement Dates FDA Received03/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2021
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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