MAUDE Adverse Event Report: C.R. BARD, INC. PISTON IRRIGATION TRAY WITH 70CC PISTON SYRINGE; SYRINGE, IRRIGATING (NON DENTAL)

Model Number 750310

Device Problems Leak/Splash (1354); Defective Device (2588)

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

Event Date 05/11/2020

Event Type  malfunction  

Event Description

For the past few weeks, i have noticed that the piston syringes are not working correctly.They lose their seal after 40-50 ml and the medication leaks out both ends.I never spoke with anyone about this until today when i found out that he entire unit has been having this issue for the past several weeks including leaking medications and tube feeds on the floors and all over the patients.The syringe appeared to get a little larger in diameter at the end, which diminished suction and allowed for leakage.

• Brand Name: PISTON IRRIGATION TRAY WITH 70CC PISTON SYRINGE
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): C.R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10307239
• MDR Text Key: 199851011
• Report Number: 10307239
• Device Sequence Number: 1
• Product Code: KYZ
• 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: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 750310
• Device Catalogue Number: 5044
• Device Lot Number: NGEN4274
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/13/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7665 DA