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

Model Number	045390
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the tip of the dormia stone basket was kinked once the doctor opened the package.
Event or Problem Description
It was reported that the tip of the dormia stone basket was kinked once the doctor opened the package.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was not used on a patient, but is intended to be used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be "improper strain relief material".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required as the reported event is unlikely to be caused by the user.Correction: h.H11: section a through f - the information provided by bd represents all 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.

• Brand Name: BARD® PLATINUM CLASS¿ II FLAT WIRE STONE BASKET
• Common Device Name: STONE BASKET
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12981724
• Report Number: 1018233-2021-07959
• Device Sequence Number: 11969435
• Product Code: FFL
• UDI-Device Identifier: 00801741066900
• UDI-Public: (01)00801741066900
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2024
• Device Model Number: 045390
• Device Catalogue Number: 045390
• Device Lot Number: BMDUMM09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 12/12/2021
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown