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

Model Number	042824
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
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 customer received a partial order of quite a few 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 notification from investigator on (b)(6) 2022 based on sample returned, it was reported that the dilation catheters were corroded.
Event or Problem Description
It was reported that the customer received a partial order of quite a few 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 notification from investigator on 04feb2022 based on sample returned, the additional records were created based on the material numbers of the samples received.The returned material numbers were (042814), (042816), (042820), (042824), (042826) and (042828).
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.The dhr review could not be performed without a lot number.As the reported event is unconfirmed a labeling review is not required.The actual/suspected device was evaluated.

• Brand Name: BARD® GOODWIN SOUND
• Common Device Name: DILATION CATHETER
• 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: 13635912
• Report Number: 1018233-2022-00952
• Device Sequence Number: 20102725
• Product Code: FBX
• UDI-Device Identifier: 00801741047282
• UDI-Public: (01)00801741047282
• 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,Followup
• Report Date (Section B): 04/20/2022

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: 042824
• Device Catalogue Number: 042824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 05/16/2022
• 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