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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; HYPODERMIC SINGLE LUMEN NEEDLE
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BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number 328411
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/02/2023
Event Type  malfunction  
Event Description
It was reported that the bd ultra-fine¿ insulin syringe had the hub separate from the device.Verbatim: daughter of consumer reported when injecting.Insulin leaks out of the hub, where meeting the barrel of syringe.Resulting of wasting of insulin.It runs down.Stomach/site daughter of consumer reported needle hub separates at times from syringe too.
 
Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
 
Event Description
It was reported that the bd ultra-fine¿ insulin syringe had the hub separate from the device.Verbatim: daughter of consumer reported when injecting.Insulin leaks out of the hub, where meeting the barrel of syringe.Resulting of wasting of insulin.It runs down.Stomach/site daughter of consumer reported needle hub separates at times from syringe too.
 
Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 23-jan-2024.H.6.Investigation summary: samples were received and an investigation was performed.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.Embecta was not able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.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 the bd ultra-fine¿ insulin syringe had the hub separate from the device.The following information was provided by the initial reporter: daughter of consumer reported when injecting.Insulin leaks out of the hub, where meeting the barrel of syringe.Resulting of wasting of insulin.It runs down.Stomach/site daughter of consumer reported needle hub separates at times from syringe too.
 
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Brand Name
BD ULTRA-FINE¿ INSULIN SYRINGE
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
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
jennifer suh
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key18011981
MDR Text Key326621621
Report Number1920898-2023-00738
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382908411035
UDI-Public(01)00382908411035
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 01/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number328411
Device Lot Number1026137
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received01/25/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2021
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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