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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 6MM 10BAG 500CS PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 6MM 10BAG 500CS PISTON SYRINGE Back to Search Results
Model Number 324911
Device Problem Defective Device (2588)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2021
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. (b)(4).
 
Event Description
It was reported that 2 syringe 0. 5ml 31ga 6mm 10bag 500cs had damaged thumb presses before use. The following was reported by the initial reporter: "it was reported that the consumer found two syringes with the plunger thumb press broken. Verbatim: consumer reported found 2 syringes with broken plunger thumb press. Lot #: 0111938. Catalog#: 324911. Date of event: unknown. Samples status awaiting sample - 1 out the 2 syringes. No replacement and informed consumer. Several cases in snow consumer deals with kaiser pharmacy".
 
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Brand NameSYRINGE 0.5ML 31GA 6MM 10BAG 500CS
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
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11369851
MDR Text Key242282194
Report Number1920898-2021-00216
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 04/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number324911
Device Catalogue Number324911
Device Lot Number0111938
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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