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

Catalog Number 750307

Device Problems Fluid/Blood Leak (1250); Suction Problem (2170)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event 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.

Manufacturer Narrative

Upon further review, bard/bd has determined that this mdr was reported in error as this event is not reportable.

Event 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
• Type of Device: IRRIGATION TRAY SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9805690
• MDR Text Key: 185523443
• Report Number: 1018233-2020-01643
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 00801741051111
• UDI-Public: (01)00801741051111
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 02/21/2020
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 04/09/2020
• Supplement Dates FDA Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1