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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 03/24/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1242719, medical device expiration date: 30-sep-2026, device manufacture date: 30-aug-2021.Medical device lot #: 9343317, medical device expiration date: 31-jan-2025, device manufacture date: 19-dec-2019.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 an unspecified number of bd veo¿ insulin syringes with bd ultra-fine¿ needles experienced scale marking issues.The following information was provided by the initial reporter: the imprint of unit of measure are not accurate, faded, missing, etc.Plungers over-sized.
 
Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval: yes.D9: returned to manufacturer on: 25-apr-2022.H6: investigation summary: customer returned 3 images, showing 3 separate syringes.The 1st syringe cannot be fully identified using the limited information available.The graduation marks appear to be slightly below their intended position and appear crooked.However, these markings cannot be directly measured using the designated graduation marking gauges since the sample has not been returned.The markings are not sufficiently out of place to be able to confirm the issue without measurement in the aforementioned gauges.The issue of a defective scale cannot be confirmed without directly measuring the syringe.The 2nd image states that the related syringe is a 0.3ml, 31 gauge, 6mm syringe from lot 1242719.The plunger rod has broken off roughly 1-2cm from its base.The fracture profile is not visible from the provided angle to show the nature of the fracture.No immediately observable issues with the black rubber stopper which could potentially show if the plunger had any difficulty being moved in the syringe barrel.The 3rd image states that the related syringe is a 0.3ml, 31 gauge, 6mm syringe from lot 9343317.The horizontal bars marking the syringe¿s graduation markings in between the 15th and 20th units are faint and not fully legible, seeming to terminate close to the base vertical marking.Customer also returned a total of (25) 0.3ml syringes with no other identification.20 of the returned syringes were found to have plungers that were difficult to move up and down the length of the syringe.1 was the syringe with the broken plunger rod in the 2nd image and was noted to also have a plunger that was difficult to move up and down.The remaining 3 featured stoppers that had separated from their plunger rods.This issue will be addressed in complaint (b)(4).A review of the device history record was completed for batch # 9343317 all inspections were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Based on the images received, embecta was unable to confirm the customer¿s indicated failure of the scale markings being misaligned.Root cause cannot be determined at this time as the issue is unconfirmed.
 
Event Description
It was reported that an unspecified number of bd veo¿ insulin syringes with bd ultra-fine¿ needles experienced scale marking issues.The following information was provided by the initial reporter: the imprint of unit of measure are not accurate, faded, missing, etc.Plungers over-sized.
 
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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 Key14138417
MDR Text Key289504277
Report Number1920898-2022-00245
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
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 06/15/2022
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 NumberSEE H10
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/24/2022
Initial Date FDA Received04/18/2022
Supplement Dates Manufacturer Received06/08/2022
Supplement Dates FDA Received06/24/2022
Was Device Evaluated by Manufacturer? Yes
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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