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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 324919
Device Problem Material Puncture/Hole (1504)
Patient Problem Needle Stick/Puncture (2462)
Event Date 07/23/2021
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.
 
Event Description
It was reported that 1 bd syringe 0. 3ml 31g 6mm had the cannula pierce the shield. The following information was provided by the initial reporter : it was reported by the pharmacist that the needle is through the shield and the consumer was stuck by the needle. Date of event : (b)(6) 2021. Samples : available.
 
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Brand NameSYRINGE 0.3ML 31G 6MM
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 Key12351193
MDR Text Key267649518
Report Number1920898-2021-00916
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number324919
Device Lot Number0286306
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/12/2020
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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