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

Model Number 042820

Device Problem Corroded (1131)

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

Event Date 02/04/2022

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 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 03feb2022 based on sample returned, it was reported that the dilation catheters were corroded.

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.Two, 20 fr sound dilator were returned.No rusting or discoloration was noted.Device meets specifications per the visual requirements which states "surface must have a mirror bright finish".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.Correction: h.H11: section a through f - the information provided by bd represents all 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.

Event 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 03feb2022 based on sample returned, the additional records were created based on the material numbers of the samples received.

Event 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.

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.Two, 20 fr sound dilator were returned.No rusting or discoloration was noted.Device meets specifications per the visual requirements which states "surface must have a mirror bright finish".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.Correction: b.H11: section a through f - the information provided by bd represents all 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 actual/suspected device was inspected.

• Brand Name: BARD® GOODWIN SOUND
• Type of Device: 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: 13635898
• MDR Text Key: 286674669
• Report Number: 1018233-2022-00951
• Device Sequence Number: 1
• Product Code: FBX
• UDI-Device Identifier: 00801741047268
• UDI-Public: (01)00801741047268
• 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,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 042820
• Device Catalogue Number: 042820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2022
• 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