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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE¿ INSULIN SYRINGE

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BD MEDICAL - DIABETES CARE BD SAFETYGLIDE¿ INSULIN SYRINGE Back to Search Results
Catalog Number 928856
Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/16/2018
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: n/a. 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 during use of the bd safetyglide¿ insulin syringe while drawing the insulin from his vile of medication the needle separated from the hub and got stuck inside vile. There was no report of injury or medical intervention. ¿.
 
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Brand NameBD SAFETYGLIDE¿ INSULIN SYRINGE
Type of DeviceINSULIN 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
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7245423
MDR Text Key99221195
Report Number1920898-2018-00030
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 03/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number928856
Device Lot Number7191702
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 Received01/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2017
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: 02/06/2018 Patient Sequence Number: 1
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