MAUDE Adverse Event Report:; SYRINGE, PISTON

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.

• Brand Name: UNK
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 7910592
• MDR Text Key: 121870432
• Report Number: MW5080143
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR