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

Model Number 041900

Device Problems Disconnection (1171); Material Fragmentation (1261)

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

Event Date 12/16/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the handle part of the stone basket was damaged. The green part of the handle came off when the package was opened.

• Brand Name: BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET
• Type of Device: NITINOL 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: 13121341
• Report Number: 1018233-2021-08594
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00801741111518
• UDI-Public: (01)00801741111518
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 041900
• Device Catalogue Number: 041900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sex: No Answer Provided
• Patient Weight: KG
• Patient Outcome(s): Other