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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 6MM 90 PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 6MM 90 PISTON SYRINGE Back to Search Results
Model Number 324908
Device Problems Delivered as Unsterile Product (1421); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is pending but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that 1 syringe 1. 0ml 6mm 90 had product damaged and a sterility issue. The following information was provided by the initial reporter : the consumer reported that one of the syringes in the bag was missing the shield, the bag was sealed and the shield was not in the bag with the needle also exposed. Date of event : (b)(6) 2021. Samples: available.
 
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Brand NameSYRINGE 1.0ML 6MM 90
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 Key12206743
MDR Text Key263392164
Report Number1920898-2021-00800
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903249084
UDI-Public00382903249084
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170386
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 07/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number324908
Device Catalogue Number324908
Device Lot Number0140383
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2020
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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