MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD PISTON IRRIGATION TRAY WITH 70ML PISTON SYRINGE; IRRIGATION TRAY SYRINGE

Catalog Number	750307
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that the piston syringe does not hold any suction so it does not hold the fluid, resulting in the patient and bed getting wet.
Additional Manufacturer Narrative
Upon further review, bard/bd has determined that this mdr was reported in error as this event is not reportable.
Event or Problem Description
It was reported that the piston syringe does not hold any suction so it does not hold the fluid, resulting in the patient and bed getting wet.

• Brand Name: BARD PISTON IRRIGATION TRAY WITH 70ML PISTON SYRINGE
• Common Device Name: IRRIGATION TRAY SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9805690
• Report Number: 1018233-2020-01643
• Device Sequence Number: 2909681
• Product Code: KYZ
• UDI-Device Identifier: 00801741051111
• UDI-Public: (01)00801741051111
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2020

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 Expiration Date: 12/31/2022
• Device Catalogue Number: 750307
• Device Lot Number: NGDZ0720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1