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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 328278
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/28/2022
Event Type  malfunction  
Event Description
It was reported that an unspecified number of bd insulin syringes with bd ultra-fine¿ needles experienced the cannula breaking off.The following information was provided by the initial reporter: consumer stated there is a problem with bd syringes.Stated, needles are breaking off in his skin but he is able to remove some it doesn't matter which lot he uses.
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter state: this was determined based on the area code portion of the provided phone #.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
Investigation summary 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# 9196165.All inspections were performed per the applicable operations qc specification.
 
Event Description
It was reported that an unspecified number of bd insulin syringes with bd ultra-fine¿ needles experienced the cannula breaking off.The following information was provided by the initial reporter: consumer stated there is a problem with bd syringes.Stated, needles are breaking off in his skin but he is able to remove some it doesn't matter which lot he uses.
 
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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 Key15666274
MDR Text Key302342047
Report Number1920898-2022-00736
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903282784
UDI-Public00382903282784
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number328278
Device Catalogue Number328278
Device Lot Number9196165
Was Device Available for Evaluation? No
Date Manufacturer Received11/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2019
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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