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

Catalog Number 750307

Device Problem Fluid/Blood Leak (1250)

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 normal saline began to leak from the piston syringe during use.

Manufacturer Narrative

Upon further review, bard/bd has determined that this mdr was reported in error as this event is not reportable.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that normal saline began to leak from the piston syringe during use.

• Brand Name: BARD PISTON IRRIGATION TRAY WITH 70ML PISTON SYRINGE, ALCOHOL WIPE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10155425
• MDR Text Key: 195626714
• Report Number: 1018233-2020-03847
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 750307
• Device Lot Number: NGDZ2066
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR