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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (BASD) -3006260740 BARD TRIALYSIS CATHETER; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED Back to Search Results
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.
 
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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 Key18378476
MDR Text Key331175355
Report Number3006260740-2023-05795
Device Sequence Number1
Product Code NIE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
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 NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/21/2023
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 Number1
Patient Outcome(s) Death;
Patient Age61 YR
Patient SexMale
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