MAUDE Adverse Event Report: C. R. BARD, INC. PISTON IRRIGATION TRAY; SYRINGE, IRRIGATING (NON DENTAL)

Model Number	PK7644960
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A surgical physician assistant stated that this product was very difficult to use.When the syringe is filled to the 70ml mark, it self ejects to the 40ml mark.It also sticks, which makes it impossible to use single handed.

• Brand Name: PISTON IRRIGATION TRAY
• Common Device Name: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10137532
• Report Number: 10137532
• Device Sequence Number: 19368725
• Product Code: KYZ
• UDI-Device Identifier: 00801741051128
• UDI-Public: (01)00801741051128(17)250131(10)NGEN4274
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2020
• Report Date (Section F): 05/14/2020

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: PK7644960
• Device Catalogue Number: 750310
• Device Lot Number: NGEN4274
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2020
• 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: 05/14/2020