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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYRINGE, PISTON

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SYRINGE, PISTON Back to Search Results
Device Problem Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/15/2018
Event Type  Injury  
Event Description
Pt's needle bent while trying to insert it into the enbrel vial. I will enter more needles to be dispensed with her enbrel future does. She lost the contents of 1 vial and needs replacement ¿ i gave her mfr phone number to contact them to see if she is eligible for replacement. If not, asked her to call us and ask for resolutions to see if she has the lost/damaged/stolen or avail on her insurance. She will also call her local pharm to see if they can give her extra needles to her next shipment from us. Rph. Route: subcutaneous. Dates of use: 2008 - present. Diagnosis or reason for use: m06. 9. The product is not compounded; the product is not over-the-counter.
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Brand NameUnknown Brand Name
MDR Report Key7910592
MDR Text Key121870432
Report NumberMW5080143
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 09/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage