MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 ALL SILICONE CATHETER; UNKNOWN SILICONE CATHETER

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Erosion (1750); Tissue Breakdown (2681)

Event Date 12/22/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 20 separate datix incident reports of urethral injury from bard foley catheters had been received.The injuries range from unclassified to 1.5 cm erosion.It was stated that this patient had ha urethral damage of 0.3 cm (patient #18).The number of patients involved were 20.It was stated that the tissue viability team were contacted and all patients were treated appropriately for their injury.

Event Description

It was reported that 20 separate datix incident reports of urethral injury from bard foley catheters had been received.The injuries range from unclassified to 1.5 cm erosion.It was stated that this patient had ha urethral damage of 0.3 cm (patient #18).The number of patients involved were 20.It was stated that the tissue viability team were contacted and all patients were treated appropriately for their injury.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿materials of construction are not biocompatible".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.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 device was not returned.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿materials of construction are not biocompatible".The provided lot number was invalid therefore dhr review can¿t be completed.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.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 device was not returned.

Event Description

It was reported that 20 separate datix incident reports of urethral injury from bard foley catheters had been received.The injuries range from unclassified to 1.5 cm erosion.It was stated that this patient had ha urethral damage of 0.3 cm (patient #18).The number of patients involved were 20.It was stated that the tissue viability team were contacted and all patients were treated appropriately for their injury.

• Brand Name: ALL SILICONE CATHETER
• Type of Device: UNKNOWN SILICONE 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16930609
• MDR Text Key: 315207494
• Report Number: 1018233-2023-03401
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 05/18/2023; 07/20/2023
• Supplement Dates FDA Received: 06/07/2023; 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention