MAUDE Adverse Event Report: SILICONE SYRINGES; SYRINGE, PISTON

Device Problems Labelling, Instructions for Use or Training Problem (1318); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Description

Berinert inj 500 units/vial was special ordered by the hospital pharmacy for a patient undergoing a scheduled surgery.The pharmacy management researched the dosing, preparation, and administration etc.Prior to the patient visit so that pharmacy and nursing would be educated.This information was distributed to appropriate staff.It was discussed in the pharmacy daily safety huddle.We were ready, right? no.The product information recommends use of silicone free syringes for preparation, an item not routinely stocked by hospitals and which do not come with the product.The box was not opened ahead of time, since it is an expensive medication.It was assumed the syringes were in the box as other products requiring silicone free syringes have this supplied, especially since these are intended for the consumer patient to prepare independently.When we inquired, the manufacturer said non silicone free syringes could be used but there is some risk of product breakdown.The pharmacy staff prepared the product using non silicone free syringes.Poor product design: (i.E.Vial, syringe, bag) confusing/incomplete information (label/labeling) poor packaging design poor label design (physical label): label misleading or difficult to read regulatory.(b)(6).Submission id: (b)(4).

• Brand Name: SILICONE SYRINGES
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 12814983
• MDR Text Key: 280936231
• Report Number: MW5105335
• Device Sequence Number: 2
• Product Code: FMF
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/16/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2021
• Patient Sequence Number: 1