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

Model Number PK7644960

Device Problem Ejection Problem (4009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/07/2020

Event Type  malfunction  

Event 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
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10137532
• MDR Text Key: 194638006
• Report Number: 10137532
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 00801741051128
• UDI-Public: (01)00801741051128(17)250131(10)NGEN4274
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PK7644960
• Device Catalogue Number: 750310
• Device Lot Number: NGEN4274
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1