MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER TRIALYSIS; ACUTE DIALYSIS CATHETER

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	08/17/2025
Type of Reportable Event	Serious Injury
Additional 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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported, patient was placed with the trialysis line.In less than 24 hours, when drew blood from the line about at least 40cc of air was drawn, ct scan also indicates air at the left side of the neck, patient currently under observation and supportive measures for air embolism.No other information was provided.
Additional 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 complaint of air leakage through the catheter is inconclusive because the failure could not be replicated.One 15 cm trialysis catheter was returned for evaluation.An initial visual observation of the returned catheter showed blood residues throughout the returned catheter.A functional test of attempting to infuse water into each lumen of the catheter using a 12 ml syringe revealed the catheter to be patent to infusion with no observable leaks.A functional test of attempting to aspirate water through each of the lumens using a 12 ml syringe revealed the catheter aspirated water without observable air leakage.A functional test of pressurizing each lumen with water revealed no observable leaks throughout the catheter; however, due to the large french size of the catheter, it could not be determined whether pressurizing the catheter correctly simulated complete blockage of the distal end of each lumen of the catheter.A microscopic observation revealed nothing remarkable throughout the catheter.Because exact clinical conditions could not be replicated, the complaint of air leakage through the catheter is inconclusive at this time.Possible contributing factors may include luer connection to their respective devices or other unknown conditions.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWER TRIALYSIS
• Common Device Name: ACUTE DIALYSIS CATHETER
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23000491
• Report Number: 3006260740-2025-06702
• Device Sequence Number: 9469085
• Product Code: NIE
• UDI-Device Identifier: 00801741086953
• UDI-Public: (01)00801741086953(11)250415(17)260630(10)REKQ2573
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 5605150
• Device Lot Number: REKQ2573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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: Required Intervention
• Patient Sex: Unknown