MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® DIMENSION® STONE BASKET; BARD DIMENSION ARTICULATION STONE BACKET/GRASPER 10MM

Model Number 043310

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Injury (2348); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.

Event Description

It was reported that a few injuries occured perioperatively.When asked why the benefits of using the stone basket product did not outweigh the potential risks, the respondent said "peu de blessures en péri opératoires" meaning "few injuries perioperatively".

Event Description

It was reported that a few injuries occured preoperatively.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿if resistance is encountered during advancement or withdrawal of the device, stop and determine the source of resistance, as continued resistance may damage the device and could result in patient injury." 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.H3 other text : the device was not returned.

• Brand Name: BARD® DIMENSION® STONE BASKET
• Type of Device: BARD DIMENSION ARTICULATION STONE BACKET/GRASPER 10MM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9469340
• MDR Text Key: 175104216
• Report Number: 1018233-2019-07972
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00801741066832
• UDI-Public: (01)00801741066832
• 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,study
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 043310
• Device Catalogue Number: 043310
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other