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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEVA PHARMACEUTICALS USA ENOXAPARIN INJECTION USP SYRINGE

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TEVA PHARMACEUTICALS USA ENOXAPARIN INJECTION USP SYRINGE Back to Search Results
Lot Number AA19034
Device Problems Break (1069); Material Separation (1562); Device Fell (4014)
Patient Problem Needle Stick/Puncture (2462)
Event Date 10/21/2020
Event Type  malfunction  
Event Description
Rn had a needle stick injury from a syringe with needle that no one on the unit could identify readily. After investigation we compared it to another lovenox auto shield injection and realized it was the inside of one of those devices. Basically after deploying the safety device the entire inside of the device fell out landed in the bed and was later the cause of the needle stick. When i pulled a new one out of the pyxis to compare, the packaging broke right in the middle of the device. This happened when i separated one from the rest of the sheet of them. I do believe the way these tear off the sheet is what caused the damage to the syringe and ultimately lead to it coming apart.
 
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Brand NameENOXAPARIN INJECTION USP
Type of DeviceSYRINGE
Manufacturer (Section D)
TEVA PHARMACEUTICALS USA
1090 horsham rd
north wales PA 19454
MDR Report Key10746918
MDR Text Key213442757
Report Number10746918
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberAA19034
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/22/2020
Event Location Hospital
Date Report to Manufacturer10/28/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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