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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE INSULIN SYRINGES, 1ML 30G X 1/2; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD ULTRA-FINE INSULIN SYRINGES, 1ML 30G X 1/2; PISTON SYRINGE Back to Search Results
Model Number 329406
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: na.Initial reporter state: address information was not able to be obtained, however, nj 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 on shelf pack with a bd ultra-fine¿ insulin syringes, 1ml 30g x 1/2.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.
 
Event Description
It was reported that the expiration date was missing on shelf pack with a bd ultra-fine¿ insulin syringes, 1ml 30g x 1/2.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# 6312688.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.This batch was manufactured before expiration dates were printed on packaging.
 
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Brand Name
BD ULTRA-FINE INSULIN SYRINGES, 1ML 30G X 1/2
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key11387846
MDR Text Key251449190
Report Number1920898-2021-00243
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903294060
UDI-Public00382903294060
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 Number329406
Device Catalogue Number329406
Device Lot Number6312688
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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