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

Model Number	042826
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the goodwin sound dilators had determined to be rusting inside the lumen of the sound.Per follow up information received via email on 24jun2020, the complainant provided 6 product catalog number with the issue.
Event or Problem Description
It was reported that the goodwin sound dilators had determined to be rusting inside the lumen of the sound.Per follow up information received via email on 24jun2020, the complainant provided 6 product catalog number with the issue 042822 , 042830 , 042828 , 042820 , 042826 and 042824.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.A heyman goodwin sound was returned without its original packaging.Rusting was noted near where the sound "funnel" meets the "shaft".A potential root cause could be due to "material selection".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "visual inspection ¿ examine each device for cleanliness.¿ if visible soil remains, repeat manual cleaning instructions.Verify that devices are free of deformations (e.G.Bent, broken, corroded, cracked, worn, or fractured) that may impact its intended use.Do not use the product if it is damaged or defective.¿ for devices that fail visual inspection, handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations for disposal of biohazardous waste.¿ products have been validated per the instructions provided.Any deviations must be validated by the user.Sterilization, storage, and replacement ¿ devices should be sterilized in accordance with the manufacturer¿s instructions using dynamic-air-removal steam sterilization (pre-vacuum).¿ devices should be clean, dry, and double-wrapped with hospital sterilization wrap.A sterilization tray may also be used according to the manufacturer¿s instructions.¿ sterilization cycle parameters: exposure time 4 minutes, exposure temperature 132°c (270°f), and drying time 30 minutes ¿ allow device to cool to room temperature after sterilization before handling.¿ any deviations from the instructions provided must be validated by the user.¿ store products in a dry and clean environment.".

• Brand Name: BARD GOODWIN SOUND
• Common Device Name: HEYMAN-GOODWIN SOUNDS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10285392
• Report Number: 1018233-2020-04592
• Device Sequence Number: 3359057
• Product Code: KOE
• UDI-Device Identifier: 00801741047299
• UDI-Public: (01)00801741047299
• 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: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2020

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: Health Professional
• Device Model Number: 042826
• Device Catalogue Number: 042826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1