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U.S. Department of Health and Human Services

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

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BD MEDICAL - DIABETES CARE BD SAFETY-LOK¿ INSULIN SYRINGE Back to Search Results
Catalog Number 329460
Device Problem Device Difficult to Setup or Prepare (1487)
Patient Problem Needle Stick/Puncture (2462)
Event Date 06/07/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. (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 the bd safety-lok" insulin syringe was difficult to operate and the safety mechanism is not being activated. Nurse technician had a needle stick injury. Due the needle stick there was contact with the patient blood and the professional. Rapid test performed in the patient and the professional. Found during use.
 
Manufacturer Narrative
Correction from expiration date 09/30/2018 to expiration date: 09/30/2019.
 
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Brand NameBD SAFETY-LOK¿ 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 Key7650450
MDR Text Key112733774
Report Number1920898-2018-00446
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Expiration Date09/30/2019
Device Catalogue Number329460
Device Lot Number4176651
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/25/2014
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: 06/29/2018 Patient Sequence Number: 1
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