MAUDE Adverse Event Report: DYNAREX CORPORATION SYRINGES (W/O NEEDLE); SYRINGE, PISTON

Model Number	6990
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The quality of the wings and plungers on the syringe is subpar and are bending under pressure while attempting insertion into patient.

• Brand Name: SYRINGES (W/O NEEDLE)
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): DYNAREX CORPORATION; 10 glenshaw st; orangeburg NY 10962
• MDR Report Key: 13900959
• Report Number: 13900959
• Device Sequence Number: 4391505
• Product Code: FRN
• UDI-Device Identifier: 00616784699028
• UDI-Public: (01)00616784699028
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/15/2022
• Report Date (Section F): 03/15/2022

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: 6990
• Device Lot Number: 50359
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/15/2022