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

Model Number	6985
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction

• Brand Name: EPIRITE SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): DYNAREX CORPORATION; 10 glenshaw street; orangeburg NY 10962
• MDR Report Key: 8745254
• Report Number: 2431014-2019-00000
• Device Sequence Number: 13952998
• Product Code: FMF
• UDI-Device Identifier: 00616784698526
• UDI-Public: 00616784698526
• Combination Product (Y/N): N
• PMA/510(K) Number: K132553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2019
• Report Date (Section F): 06/11/2019

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
• Event Location: Other
• Date Report to Manufacturer: 06/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MW5087168
• Patient Sequence Number: 1