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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE Back to Search Results
Catalog Number 320440
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2023
Event Type  malfunction  
Event Description
It was reported that the bd insulin syringes with the bd ultra-fine¿ needle plunger is looser.The following information was provided by the initial reporter: for some time now, our professionals have noticed that the plunger is looser and the needle of poor quality.
 
Manufacturer Narrative
B3: date of event: unknown.The date received by manufacturer has been used for this field.H3: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D4: device expiration date: unknown.H4: device manufacture date: unknown.
 
Event Description
It was reported that the bd insulin syringes with the bd ultra-fine¿ needle plunger is looser.The following information was provided by the initial reporter: for some time now, our professionals have noticed that the plunger is looser and the needle of poor quality.
 
Manufacturer Narrative
H6: investigation summary: no samples including photos were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to the batch being unknown, no dhr review can be completed.
 
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Brand Name
BD INSULIN SYRINGES 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 Key16792176
MDR Text Key313830247
Report Number1920898-2023-00250
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number320440
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/04/2023
Initial Date FDA Received04/21/2023
Supplement Dates Manufacturer Received05/04/2023
Supplement Dates FDA Received05/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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