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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE VET SYRINGE 0.3ML X 29G X 12.7MM PISTON SYRINGE

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BD MEDICAL - DIABETES CARE VET SYRINGE 0.3ML X 29G X 12.7MM PISTON SYRINGE Back to Search Results
Model Number 323000
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/10/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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 3 vet syringe 0. 3ml x 29g x 12. 7mm hubs separated. The following information was provided by the initial reporter : the consumer reported that when needle shields were removed the needle hubs separated.   date of event: unknown. Samples: yes.
 
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Brand NameVET SYRINGE 0.3ML X 29G X 12.7MM
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12125820
MDR Text Key262694545
Report Number1920898-2021-00726
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,distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number323000
Device Catalogue Number323000
Device Lot Number0174596
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2020
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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