MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET

Model Number 041900

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2022

Event Type  malfunction  

Event Description

It was reported that there were foreign objects like hair in the skylite basket package and a new one was changed.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

The reported event was confirmed manufacturing related.A potential root cause for this failure mode could be ¿defective / contaminated components from supplier".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The investigation is concluded, and no additional action is required at this time.A labeling review was not performed because labelling could not have prevented the reported failure.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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that there were foreign objects like hair in the skylite basket package and a new one was changed.

• Brand Name: BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET
• Type of Device: NITINOL 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15133793
• MDR Text Key: 302850223
• Report Number: 1018233-2022-05871
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00801741111518
• UDI-Public: (01)00801741111518
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 041900
• Device Catalogue Number: 041900
• Device Lot Number: NGFZ3005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other