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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1ML 8MM (5/16") 31G U-100; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1ML 8MM (5/16") 31G U-100; PISTON SYRINGE Back to Search Results
Model Number 328418
Device Problem Complete Blockage (1094)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2022
Event Type  malfunction  
Event Description
It was reported that while using a bd insulin syringe with bd ultra-fine¿ needle 1ml 8mm (5/16") 31g u-100 100count, the syringe would not aspirate medication.The following information was provided by the initial reporter: consumer reported syringe would not draw medication.
 
Manufacturer Narrative
Date of event: the date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 28-mar-2022.H.6.Investigation: customer returned a single 1ml syringe.Syringe did not feature any immediately observable damage.Water was drawn into the syringe to full without issue.No defects were found and the syringe functioned as intended.A review of the device history record was completed for batch# 9294934.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause cannot be determined at this time as the issue is unconfirmed.
 
Event Description
It was reported that while using a bd insulin syringe with bd ultra-fine¿ needle 1ml 8mm (5/16") 31g u-100 100count, the syringe would not aspirate medication.The following information was provided by the initial reporter: consumer reported syringe would not draw medication.
 
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Brand Name
BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1ML 8MM (5/16") 31G U-100
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 Key13892620
MDR Text Key287903133
Report Number1920898-2022-00192
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382908418034
UDI-Public00382908418034
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190054
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 04/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number328418
Device Catalogue Number328418
Device Lot Number9294934
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2019
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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