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

Model Number 039690

Device Problems Material Fragmentation (1261); Device Handling Problem (3265)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2020

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 one dormia probe was broken when the box was opened and basket rod not attached to the handle.For the second probe, the rod had detached from the handle after a single use and without even forcing it.Both were from the same lot.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 one dormia probe broken when the box was opened and basket rod not attached to the handle.For the second probe, the rod had detached from the handle after a single use and without even forcing it.Both were from the same lot.

Event Description

It was reported that one dormia probe broken when the box was opened and basket rod not attached to the handle.For the second probe, the rod had detached from the handle after a single use and without even forcing it.Both were from the same lot.

Manufacturer Narrative

The reported event is confirmed.A potential root cause for failure mode " detached basket rod" could be due to the user being unfamiliar with the packaging.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "handle disassembly/reassembly: if handle removal is desired: 1.Unscrew the thumb screw located on the basket handle.2.Gently pull backward on the handle, releasing both the handle and sheath from the drivewire/basket combination.If any resistance is felt at this stage, stop and determine cause of resistance.3.Once the stone burden within the basket has been removed, the basket can be closed using an opentip ureteral catheter.4.The basket can be reassembled easily by inserting the drivewire into the sheath and advancing until it reaches the handle.5.Tighten the thumb screw to secure the drivewire in place." h11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was evaluated.

• Brand Name: BARD PLATINUM CLASS II FLAT WIRE STONE BASKET
• Type of Device: BARD FLATWIRE STONE BASKETS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10755764
• MDR Text Key: 213680808
• Report Number: 1018233-2020-20551
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00801741076558
• UDI-Public: (01)00801741076558
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: 039690
• Device Catalogue Number: 045290
• Device Lot Number: BMBUMM11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other