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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 324910
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/02/2022
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 bd veo¿ insulin syringes with bd ultra-fine¿ needles experienced 100 cases of scale marking issues.The following information was provided by the initial reporter: the very first scale mark (the zero point) is way lower than it should be, which makes me inject more insulin than measured.
 
Manufacturer Narrative
H.6.A complaint lot history check was performed on lot # 1144160 for scale misaligned.This is the 1st related complaint for scale misaligned on lot # 1144160.Investigation summary: customer returned (3) 0.3ml syringes.Each of the syringes were measured using a gauge pertaining to the positioning of the graduation marks.While the graduation marks on all of the syringes were found to have placed lower along the barrel of the syringe than average, all of the graduation marks were still within acceptable values.A review of the device history record was completed for batch # 1144160 all inspections were performed per the applicable operations qc specifications.There was one (1) notification [(b)(4)] noted that did not pertain to the complaint.Based on the samples received, embecta was unable to confirm the customer¿s indicated failure of the scale markings being misaligned.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause cannot be determined at this time as the issue is unconfirmed.Based on the investigation, no capa/sa is required at this time.
 
Event Description
It was reported that bd veo¿ insulin syringes with bd ultra-fine¿ needles experienced 100 cases of scale marking issues.The following information was provided by the initial reporter: the very first scale mark (the zero point) is way lower than it should be, which makes me inject more insulin than measured.
 
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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 Key14438281
MDR Text Key292359856
Report Number1920898-2022-00346
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K190054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/16/2022
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 Number324910
Device Lot Number1144160
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/02/2022
Initial Date FDA Received05/19/2022
Supplement Dates Manufacturer Received06/16/2022
Supplement Dates FDA Received07/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2021
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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