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

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 they had 8 syringes with leaking issues.One of the syringes was used, and 7 were not used.

Event Description

It was reported that they had 8 syringes with leaking issues.One of the syringes was used, and 7 were not used.

Manufacturer Narrative

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

• Brand Name: BARD PISTON IRRIGATION TRAY WITH 70ML PISTON SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9853542
• MDR Text Key: 186333596
• Report Number: 1018233-2020-01936
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• 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: NGDY3469
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1