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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; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH BD ULTRA FINE¿ NEEDLE; PISTON SYRINGE Back to Search Results
Model Number 328291
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2022
Event Type  malfunction  
Event Description
It was reported that the bd insulin syringes with bd ultra fine¿ needle experienced hub separation from the device.The following information was provided by the initial reporter: consumer reported needle hub separated inside of the hub.
 
Manufacturer Narrative
Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
Date of event: unknown.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 insulin syringes with bd ultra fine¿ needle experienced hub separation from the device.The following information was provided by the initial reporter: consumer reported needle hub separated inside of the hub.
 
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Brand Name
BD 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 Key13456524
MDR Text Key285238865
Report Number1920898-2022-00071
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903282913
UDI-Public00382903282913
Combination Product (y/n)N
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
Report Date 01/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number328291
Device Catalogue Number328291
Device Lot Number9161979
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2019
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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