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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE Back to Search Results
Model Number 328438
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2023
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.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.
 
Event Description
It was reported that 2 bd insulin syringes with the bd ultra-fine¿ needle had issues with the needle separating from the hub.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "customer reached out to let me know that she opened a brand new bag of beauty syringes and was stuck.There were needles sticking out and not capped (1) broken off cap and a couple syringes are dull.This happen this morning in her office as she was preparing for a beauty patient.No patient was involved practioner was stuck with the uncapped needle.".
 
Manufacturer Narrative
H.6.Investigation summary: no samples were returned therefore the investigation is performed based on the photos provided.The customer provided (4) photos of 0.3ml 31ga 8mm syringes.The photos were visually examined and observed needle hub separation.Based on the photos provided, embecta was able to confirm the reported failure.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.
 
Event Description
It was reported that 2 bd insulin syringes with the bd ultra-fine¿ needle had issues with the needle separating from the hub.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "customer reached out to let me know that she opened a brand new bag of beauty syringes and was stuck.There were needles sticking out and not capped (1) broken off cap and a couple syringes are dull.This happen this morning in her office as she was preparing for a beauty patient.No patient was involved practioner was stuck with the uncapped needle.".
 
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Brand Name
BD INSULIN SYRINGE WITH THE 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
8448235433
MDR Report Key16714777
MDR Text Key313215917
Report Number1920898-2023-00212
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382908438032
UDI-Public00382908438032
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K212499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number328438
Device Catalogue Number328438
Device Lot Number1343819
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/09/2021
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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