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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE

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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE Back to Search Results
Model Number 328440
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/05/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that 5 bd insulin syringes with the bd ultra-fine¿ needles experienced device damage/deformation while still considered operable. The following information was provided by the initial reporter: material no. 328440 batch no. Unknown. I need to report a damaged & refused on a recent po. Bd ins syr 31g 3/10cc 1/2unit 100. Damaged & refused 5.
 
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Brand NameBD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
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 Key11406743
MDR Text Key251440377
Report Number1920898-2021-00253
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 distributor,other
Reporter Occupation Other Health Care Professional
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 Received03/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number328440
Device Catalogue Number328440
Device Lot NumberUNKNOWN
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 Received04/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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