MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER; FOLEY CATHETER (SILICONE)

Catalog Number 175814

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); Sepsis (2067); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/05/2022

Event Type  Death  

Event Description

It was reported that the patient experienced a laceration during use of a foley catheter.The patient also had septicemia and passed away around on (b)(6) 2022.Clinical follow up information was received via email from the regional complaint coordinator (rcc) on (b)(6) 2022.The catheter was inserted by a district nurse (dn) in the home setting, and there was nothing abnormal noted about the device prior to insertion.The day after the catheter was inserted, the patient¿s care giver was cleaning him and noticed a 3cm long open laceration on the patient¿s scrotum, but it was unknown what caused the wound.It was noted that it looked like the catheter was inserted into the side wall of the penis, but this could not be confirmed.The patient was seen by his general practitioner (gp) to assess the wound, and cream was applied.The gp informed the patient¿s brother that the wound would likely not clear up quickly.The patient was later hospitalized for septicemia, and he passed away on (b)(6) 2022.Septicemia was listed as the cause of death on the death certificate.The patient¿s family member believed this was more of a nurse issue rather than a catheter issue.The patient did not have any recent surgeries or procedures, and the only medical history provided was dementia.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the patient experienced a laceration during use of a foley catheter.The patient also had septicemia and passed away around (b)(6) 2022.Clinical follow up information was received via email from the regional complaint coordinator (rcc) on (b)(6) 2022.The catheter was inserted by a district nurse (dn) in the home setting, and there was nothing abnormal noted about the device prior to insertion.The day after the catheter was inserted, the patient¿s care giver was cleaning him and noticed a 3cm long open laceration on the patient¿s scrotum, but it was unknown what caused the wound.It was noted that it looked like the catheter was inserted into the side wall of the penis, but this could not be confirmed.The patient was seen by his general practitioner (gp) to assess the wound, and cream was applied.The gp informed the patient¿s brother that the wound would likely not clear up quickly.The patient was later hospitalized for septicemia, and he passed away on (b)(6) 2022.Septicemia was listed as the cause of death on the death certificate.The patient¿s family member believed this was more of a nurse issue rather than a catheter issue.The patient did not have any recent surgeries or procedures, and the only medical history provided was dementia.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation to confirm any device failure, and the information collected during the investigation was not conclusive.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.In conclusion, after review of the risk management file of the device involved in the event it was determined that the most likely potential cause of the event is "user violation of standard practice" or "user oversight, user did not follow procedure".However there is no evidence to confirm it as the definitive cause.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "for urological use only" "visually inspect the product for any imperfections or surface deterioration prior to use." 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.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER (SILICONE)
• 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: 14487756
• MDR Text Key: 292494846
• Report Number: 1018233-2022-04032
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K984084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 175814
• Device Lot Number: MYFW0023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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): Death; Hospitalization
• Patient Sex: Male