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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 324912
Device Problem Device Markings/Labelling Problem (2911)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Initial reporter state: address information was not able to be obtained, however, (b)(6) was used as a place holder.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that the expiration date was missing from shelf carton with bd veo insulin syringes with bd ultra-fine needle.The following information was provided by the initial reporter: it was reported that expiration date was not on shelf carton.Consumer wanted to know if syringes were still good to use.Stated, did not see expiration date.
 
Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 7198986.All inspections were performed per the applicable operations qc specifications.There were two (2) notifications [200706056, 200706546] noted that did not pertain to the complaint.This was manufactured before expiration dates on packaging.H3 other text : see h.10.
 
Event Description
It was reported that the expiration date was missing from shelf carton with bd veo insulin syringes with bd ultra-fine needle.The following information was provided by the initial reporter: it was reported that expiration date was not on shelf carton.Consumer wanted to know if syringes were still good to use.Stated, did not see expiration date.
 
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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
MDR Report Key11387895
MDR Text Key247033729
Report Number1920898-2021-00246
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903249121
UDI-Public00382903249121
Combination Product (y/n)N
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 03/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number324912
Device Catalogue Number324912
Device Lot Number7198986
Was Device Available for Evaluation? No
Date Manufacturer Received03/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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