MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD TRIALYSIS CATHETER; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number N/A

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

Patient Problem Cardiac Arrest (1762)

Event Date 11/28/2023

Event Type  Death  

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of 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.The date of event and the date the patient expired were not provided by the complainant/reporter, the date of event and date of death reflected in this report are the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.

Event Description

It was reported by customer that overnight, patient with renal failure was admitted from the emergency department.Trialysis catheter placed for continuous renal replacement therapy.Patient intubated and on multiple vasopressors.Intensivist reports trialysis line was very difficult to thread wire through due to the amount of resistance requiring him to use significant force.Wire was able to be removed and appeared intact.A new trialysis kit was gathered and placed without difficulty.Continuous renal replacement therapy was initiated.Event delayed continuous renal replacement therapy initiation.Patient did cardiac arrest soon after initiation of crrt and expired.

• Brand Name: BARD TRIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18378476
• MDR Text Key: 331175355
• Report Number: 3006260740-2023-05795
• Device Sequence Number: 1
• Product Code: NIE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2023
• 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): Death
• Patient Age: 61 YR
• Patient Sex: Male