MAUDE Adverse Event Report: DYNAREX CORPORATION DYNAREX EPIRITE SYRINGE; PISTON SYRINGE

Model Number	6985
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Reference report number mw5087168 for incomplete syringe graduations.Note: an adverse event did not occur.A physician was reporting the issue of incomplete graduation markings on the syringe for young children.Dynarex provides a syringe that is a component in a kit, and makes no reference or recommendations regarding dosage.It is the responsibility of the kit manufacturer to determine syringe suitability and appropriateness for use as part of the finished combination kit.Dynarex did not initiate the ifu for the drug in the package insert and cannot accept responsibility for product incompatibility or syringe graduations.

• Brand Name: DYNAREX EPIRITE SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): DYNAREX CORPORATION; 10 glenshaw street; orangeburg NY 10962 1207
• MDR Report Key: 9418977
• Report Number: 2431014-2019-00002
• Device Sequence Number: 2209589
• Product Code: FMF
• UDI-Device Identifier: 00616784698526
• UDI-Public: 00616784698526
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2019
• Report Date (Section F): 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6985
• Device Catalogue Number: 6985
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/07/2019
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/06/2019