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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500 PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500 PISTON SYRINGE Back to Search Results
Model Number 328438
Device Problems Leak/Splash (1354); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/19/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that a syringe 0. 3ml 31g 8mm wholeunit 10bg 500 separated from the hub and was damaged before use. The following was reported by the initial reporter: "it was reported that needle shield could not be removed from some syringes. One needle shield was smashed and the needle hub separated when removing the needle shield. Verbatim: pet owner reported, she could not remove needle shield from some syringes stated, the needle shield was "smashed" on one syringe stated, needle hub separated, when removing needle shield".
 
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Brand NameSYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500
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 Key11679751
MDR Text Key247480414
Report Number1920898-2021-00416
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
Type of Report Initial,Followup
Report Date 05/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number328438
Device Catalogue Number328438
Device Lot Number0153971
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2020
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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