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

Model Number	042812
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer received a partial order of quite a few goodwin sound replacements as it had consistently had issues with rust 042822 and 042820 and discoloration 042816 and 042814 in the lumen.It was also stated 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 16aug2021, 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.
Additional 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.One, 26 fr sound dilator was returned.No rusting or discoloration was noted.Device meets specifications which states, "surface must have a mirror bright finish".A photo sample was also returned.No rust or discoloration was noted.The lot number was unknown; therefore, the device history record could not be reviewed.Labeling review is not required as the reported event is unconfirmed.The actual/suspected device was inspected.

• Brand Name: BARD® GOODWIN SOUND
• Common Device Name: GOODWIN SOUND
• 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: 13625905
• Report Number: 1018233-2022-00944
• Device Sequence Number: 17439908
• Product Code: FBX
• UDI-Device Identifier: 00801741047220
• UDI-Public: (01)00801741047220
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2022

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: Lay User/Patient
• Device Model Number: 042812
• Device Catalogue Number: 042826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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