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

Model Number	043310
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); No Information (3190)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem Description
It was reported that a few injuries occured preoperatively.
Additional 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
• Common Device Name: 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
• Report Number: 1018233-2019-07972
• Device Sequence Number: 2852049
• Product Code: FFL
• UDI-Device Identifier: 00801741066832
• UDI-Public: (01)00801741066832
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 043310
• Device Catalogue Number: 043310
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 01/12/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other