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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE INSULIN SYRINGES SHORT NEEDLE 31G 3/10CC 5/16IN PISTON SYRINGE

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BD MEDICAL - DIABETES CARE BD ULTRA-FINE INSULIN SYRINGES SHORT NEEDLE 31G 3/10CC 5/16IN PISTON SYRINGE Back to Search Results
Model Number 328291
Device Problems Leak/Splash (1354); Defective Device (2588)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/05/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported while using bd ultra-fine¿ insulin syringes short needle 31g 3/10cc 5/16in when removing shield the hub separated from device. There was no reported patient impact. The following information was provided by the initial reporter: it was reported that needle hub separated and shields were difficult to remove.
 
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Brand NameBD ULTRA-FINE INSULIN SYRINGES SHORT NEEDLE 31G 3/10CC 5/16IN
Type of DevicePISTON 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
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11228289
MDR Text Key228621729
Report Number1920898-2021-00106
Device Sequence Number1
Product Code FMF
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 consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number328291
Device Catalogue Number328291
Device Lot Number9161979
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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