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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; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 326631
Device Problem Missing Information (4053)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/24/2023
Event Type  malfunction  
Manufacturer Narrative
Medical 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.
 
Event Description
It was reported that the bd ultra-fine¿ insulin syringe had no scale markings on it.The following information was provided by the initial reporter, translated from japanese: "the user reported that the print on the barrel was missing.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 26-apr-2023.H6: investigation summary: the customer returned (1) 0.3ml 29ga syringe, reporting scale marking missing.The syringe was visually examined and observed missing scale markings on the barrel.Upon visual examination, embecta was able to confirm the customer-indicated failure.Due to the batch being unknown, no dhr review can be completed.
 
Event Description
It was reported that the bd ultra-fine¿ insulin syringe had no scale markings on it.The following information was provided by the initial reporter, translated from japanese: "the user reported that the print on the barrel was missing.".
 
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Brand Name
BD ULTRA-FINE¿ 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
8448235433
MDR Report Key16728212
MDR Text Key313661500
Report Number1920898-2023-00218
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeJA
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 07/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number326631
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/13/2023
Was Device Evaluated by Manufacturer? Yes
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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