MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® PLATINUM CLASS¿ II FLAT WIRE STONE BASKET

Model Number 045390

Device Problems Failure to Capture (1081); Defective Device (2588)

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.The device was not returned.

Event Description

It was reported that the product did not perform as intended, and did not result in successful stone retrieval every time they used it.The respondent stated they had to use different baskets a few times to retrieve stones.

Manufacturer Narrative

The device was not returned for evaluation.A potential root cause could be due to "wire(s) broken before patient use".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: "this is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient".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.

Event Description

It was reported that the product did not perform as intended, and did not result in successful stone retrieval every time they used it.The respondent stated they had to use different baskets a few times to retrieve stones.

• Brand Name: BARD® PLATINUM CLASS¿ II FLAT WIRE STONE BASKET
• Type of Device: STONE BASKET
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9413354
• MDR Text Key: 178577382
• Report Number: 1018233-2019-07709
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00801741066900
• UDI-Public: (01)00801741066900
• 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: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 045390
• Device Catalogue Number: 045390
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1