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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 29GA 1/2IN PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 29GA 1/2IN PISTON SYRINGE Back to Search Results
Catalog Number 328420
Device Problems Volume Accuracy Problem (1675); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/20/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone#: unknown. Initial reporter zip code: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that 3 bd syringe 1. 0 ml 29 ga 1/2 in had foreign matter on the device cannula or in the fluid path and scale marking issues. The following information was provided by the initial reporter: the distributor reported that when the syringe cap was opened the needle was found to be rusty. Also the printed contents on the surface of the syringe body were slightly worn and there were traces of residual liquid in the tube.
 
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Brand NameSYRINGE 1.0ML 29GA 1/2IN
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 Key12368128
MDR Text Key268215111
Report Number1920898-2021-00930
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328420
Device Lot Number0188698
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2020
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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