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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH NEEDLE ULTRA-FINE¿ ATTACHED NEEDLE WITHOUT SAFETY

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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH NEEDLE ULTRA-FINE¿ ATTACHED NEEDLE WITHOUT SAFETY Back to Search Results
Catalog Number 328438
Device Problems Detachment Of Device Component (1104); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/30/2018
Event Type  malfunction  
Manufacturer Narrative
Medical 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.
 
Event Description
It was reported that during use a bd insulin syringe with needle ultra-fine¿ attached needle without safety was found with "the scale print was missing before injection and also needle hub separated from syringe. " there was no report of exposure, injury or medical intervention needed.
 
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Brand NameBD INSULIN SYRINGE WITH NEEDLE ULTRA-FINE¿ ATTACHED NEEDLE WITHOUT SAFETY
Type of DeviceINSULIN SYRINGE WITH NEEDLE
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
8015652845
MDR Report Key7527576
MDR Text Key108899426
Report Number1920898-2018-00346
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 Patient
Type of Report Initial,Followup
Report Date 05/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328438
Device Lot Number6319801
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/11/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/18/2018 Patient Sequence Number: 1
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