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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 Break (1069)
Patient Problem Needle Stick/Puncture (2462)
Event Date 08/03/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: 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 1 bd syringe 0. 3ml 31g 6mm cannula broke off. The following information was provided by the initial reporter : the consumer reported that the needle breaks when inserting into the dog. Occurred date : unknown. Sample status : awaiting sample.
 
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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 Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12411338
MDR Text Key269629976
Report Number1920898-2021-00951
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328521
Device Lot Number1095001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/05/2021
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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