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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II INSULIN SYRINGE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II INSULIN SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 328328
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2022
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.Medical device lot #: 03070336 was reported, however, this is not a lot # manufactured for the reported catalog #.
 
Event Description
It was reported that the bd ultra-fine¿ ii insulin syringe experienced a sterility issue.The following information was provided by the initial reporter: customer reports that one of the syringes was without the protective cover inside the package.The cover is loose inside the package.There was no accidental perforation.The packaging is sealed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 0307033, d4: medical device expiration date: 30-nov-2025, h4: device manufacture date: 02-nov-2020.H6: investigation summary: no samples or 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# 0307033.All inspections were performed per the applicable operations qc specification.
 
Event Description
It was reported that the bd ultra-fine¿ ii insulin syringe experienced a sterility issue.The following information was provided by the initial reporter: customer reports that one of the syringes was without the protective cover inside the package.The cover is loose inside the package.There was no accidental perforation.The packaging is sealed.
 
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Brand Name
BD ULTRA-FINE¿ II INSULIN SYRINGE
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 Key15968000
MDR Text Key308442970
Report Number1920898-2022-00873
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number328328
Device Lot Number0307033
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/02/2020
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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