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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 320468
Device Problems Degraded (1153); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2022
Event Type  malfunction  
Manufacturer Narrative
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 the bd ultra-fine¿ insulin syringe melted and was found in a sealed bag.The following information was provided by the initial reporter: my reason for emailing is i have found this odd syringe in my bag of syringes: as you can see the plunger is melted (or inserted wrong?) and was found in a sealed bag.
 
Manufacturer Narrative
H6: investigation summary customer returned an image of a 0.5ml, 30 gauge, 8mm syringe from lot 1340438.The side of the syringe features a black smudge that stretches from the 5 to the 15 unit graduation marks.This mark appears to be on the inside of the syringe barrel and ends approximately at the same location as the black stopper.A review of the device history record was completed for batch# 1340438.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 images received, embecta was able to confirm the customer¿s indicated failure of a stopper defect.Root-cause cannot be determined.H3 other text : see h10.
 
Event Description
It was reported that the bd ultra-fine¿ insulin syringe melted and was found in a sealed bag.The following information was provided by the initial reporter: my reason for emailing is i have found this odd syringe in my bag of syringes: as you can see the plunger is melted (or inserted wrong?) and was found in a sealed bag.
 
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Brand Name
BD ULTRA-FINE¿ INSULIN SYRINGE
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 Key15820631
MDR Text Key307076568
Report Number1920898-2022-00813
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer
Reporter Occupation Other Health Care Professional
Remedial Action Notification
Type of Report Initial,Followup
Report Date 12/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number320468
Device Lot Number1340438
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/06/2021
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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