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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH 29 G X 1/2 IN. BD¿ NEEDLE SAFETY ENGINEERED INSULIN SYRINGE AND NEEDLE

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BD MEDICAL - DIABETES CARE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH 29 G X 1/2 IN. BD¿ NEEDLE SAFETY ENGINEERED INSULIN SYRINGE AND NEEDLE Back to Search Results
Catalog Number 305930
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/07/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Initial reporter phone#: (b)(6). 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 with use, a bd safety glide¿ insulin syringe with bd¿ permanently attached needle malfunctioned as ¿the plunger got disconnected from the main body of the syringe. " there was no report of injury or medical intervention needed.
 
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Brand NameBD SAFETYGLIDE¿ INSULIN SYRINGE WITH 29 G X 1/2 IN. BD¿ NEEDLE
Type of DeviceSAFETY ENGINEERED INSULIN SYRINGE AND 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 Key7307882
MDR Text Key101482132
Report Number1920898-2018-00099
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K992734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2021
Device Catalogue Number305930
Device Lot Number6315757
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2016
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: 03/01/2018 Patient Sequence Number: 1
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