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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 SYRINGE WITH NEEDLE

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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 328468
Device Problems Material Separation (1562); Component Missing (2306); Detachment of Device or Device Component (2907); Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/19/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. Two potential lot numbers were provided for this incident. The information for each lot number is as follows:  medical device lot #: 7177894; medical device expiration date: n/a; device manufacture date: 2017-08-25; medical device lot #: 7198833; medical device expiration date: n/a; device manufacture date: 2017-09-08. 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 there were multiple defects found with a bd insulin syringe with the bd ultra-fine¿ needle prior to use i. E. , missing stopper, stopper separation, missing scale printing prior to use. There was no report of exposure, serious injury or medical intervention.
 
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Brand NameBD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
Type of DeviceSYRINGE 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 Key7680181
MDR Text Key114018173
Report Number1920898-2018-00491
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,Followup
Report Date 08/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328468
Device Lot NumberSEE H.10.
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 Received06/19/2018
Was Device Evaluated by Manufacturer? Yes
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: 07/11/2018 Patient Sequence Number: 1
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