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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB

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BD MEDICAL - DIABETES CARE SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB Back to Search Results
Model Number 305945
Device Problems Leak/Splash (1354); Retraction Problem (1536)
Patient Problem Exposure to Body Fluids (1745)
Event Date 07/02/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that the syringe sftygld 1ml w/ndl 27x1/2 rb experienced a broken safety mechanism, blood exposure -splash, and a post use dirty needle stick injury. Product defects were noted after use. It has not been specified whether any medical intervention was received as a result of the needle stick injury. The following information was provided by the initial reporter: material no: 305945 batch no: 6131957. Safety glide needle cover deployed after tb skin test performed. Able to unlock safetyglide cover which slid back and resulted in a needlestick injury.
 
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Brand NameSYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB
Type of DeviceSYRINGE
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
8015652341
MDR Report Key10312869
MDR Text Key200044923
Report Number1920898-2020-00921
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K992734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2021
Device Model Number305945
Device Catalogue Number305945
Device Lot Number6131957
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/10/2016
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: 07/23/2020 Patient Sequence Number: 1
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