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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SILICONE SYRINGES SYRINGE, PISTON

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SILICONE SYRINGES SYRINGE, PISTON Back to Search Results
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).
 
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Brand NameSILICONE SYRINGES
Type of DeviceSYRINGE, PISTON
MDR Report Key12814983
MDR Text Key280936231
Report NumberMW5105335
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 Unknown
Type of Report Initial
Report Date 02/16/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received11/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided

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