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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD SYRINGE INSULIN SAFETY GLIDE 1 ML SYRINGE, PISTON

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BD BD SYRINGE INSULIN SAFETY GLIDE 1 ML SYRINGE, PISTON Back to Search Results
Model Number 594674
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/22/2019
Event Type  malfunction  
Event Description
Turbidity / floaters seen in novolog insulin vial. Expected that this is due to the lubricant from the insulin syringes used. Fda safety report id# (b)(4).
 
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Brand NameBD SYRINGE INSULIN SAFETY GLIDE 1 ML
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BD
MDR Report Key9069927
MDR Text Key158849996
Report NumberMW5089794
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 09/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number594674
Device Catalogue Number328446
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

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