MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® GOODWIN SOUND; GOODWIN SOUNDS

Model Number 042830

Device Problem Corroded (1131)

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

Event Date 07/15/2021

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 customer received a partial order of goodwin sound replacements, as it consistently had issues with rust and discoloration in the lumen.Also stated that upon receiving the new replacements, they were inspected with a borescope and discoloration was noted prior to any reprocessing.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.The device did not fail to meet relevant specifications.As the product was not used on a patient it was not used for diagnostic or treatment purposes.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.The device history record review could not be performed without a lot number.As the reported event is unconfirmed a labeling review is not required.Corrections: d,f,h 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.

Event Description

It was reported that the customer received a partial order of goodwin sound replacements, as it consistently had issues with rust and discoloration in the lumen.Also stated that upon receiving the new replacements, they were inspected with a borescope and discoloration was noted prior to any reprocessing.Per follow up via email on (b)(6) 2021, the lot numbers of the affected sounds which are mixed with new box and never processed.The new box, which was processed initially, never used on patient.This was the ongoing issue for the customer and consistently replacing these.The customer checked and verified internal process and follow the ifu verbatim, flushing with sterile water at point of use.The box and packaging that customer received was for 11 sounds.They have total of 24 sounds 042824 and 042826.

• Brand Name: BARD® GOODWIN SOUND
• Type of Device: GOODWIN SOUNDS
• 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: 12293564
• MDR Text Key: 265575389
• Report Number: 1018233-2021-04800
• Device Sequence Number: 1
• Product Code: FBX
• UDI-Device Identifier: 00801741047312
• UDI-Public: (01)00801741047312
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 042830
• Device Catalogue Number: 042820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Other