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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31G 6MM; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31G 6MM; PISTON SYRINGE Back to Search Results
Catalog Number 328521
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is pending but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that 1 syringe 0.3ml 31g 6mm hub separated.The following information was provided by the initial reporter : the consumer stated that the needle shields are tight and the needle hub separated and stayed inside of the shield.Date of event : (b)(6) 2021.Samples : available.
 
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Brand Name
SYRINGE 0.3ML 31G 6MM
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12239915
MDR Text Key265180679
Report Number1920898-2021-00828
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00681131138390
UDI-Public00681131138390
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 Other Health Care Professional
Type of Report Initial
Report Date 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number328521
Device Lot Number0342393
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2020
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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