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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Exsanguination (1841); Insufficient Information (4580)
Date of Event	10/21/2023
Type of Reportable Event	Death
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 date of death was not provided by the complainant/reporter.The date reflected in this report is the date of the event provided to bd.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
Customer inquired on any changes in design or manufacturing process for device.Additional information received (b)(6) 2023: it was reported by the customer "the two ports and their respective lines leading to the "y" hub (arterial and venous) became detached from the hub.This was a 79 year old white male patient weighing 77kg with a pmh significant for leukemia and gi neuroendocrine tumor who presented with weakness and encephalopathy.He developed aki which required dialysis with catheter in question.The patient coded requiring acls and the patient expired.".
Event or Problem Description
Customer inquired on any changes in design or manufacturing process for device.Additional information received 11/6/2023: it was reported by the customer "the two ports and their respective lines leading to the "y" hub (arterial and venous) became detached from the hub.This was a 79 year old white male patient weighing 77kg with a pmh significant for leukemia and gi neuroendocrine tumor who presented with weakness and encephalopathy.He developed aki which required dialysis with catheter in question.The patient coded requiring acls and the patient expired." additional information received 11/30/2023: it was reported by the customer ¿the patient was noted to have been resting comfortably prior to the code.He did have dialysis earlier in the day ~ 8 hours prior to code.The two ports and their respective lines leading to the "y" hub (arterial and venous) became detached from the hub.Cause of death was exsanguination from detachment of the dialysis catheter.Code efforts rendered immediately upon loss of pulses.Rosc not achieved.Device was noted to have been working properly, site was clean, dry, and intact.It was noted that a tegaderm was not being used at the time of the event and ports were clamped.¿.
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 is pending evaluation.Results are expected soon.
Additional Manufacturer Narrative
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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of a damaged dialysis catheter was confirmed; however, the root cause was not identified.The product returned for evaluation was two photographs which depicted a portion of a dialysis catheter.Both photographs depicted the venous and arterial extension tubes.The tubes were fully broken/detached from the rest of the device, which was not visible in either photograph.The breaks in the tubes appeared regular.Details about the fracture surfaces were not visible.Damage was clearly visible in the two submitted photographs; however, inspection of the photographs was insufficient to identify the cause of the damage.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include sharp instrument contact and tensile stress.A review of manufacturing records could not be conducted as product batch details were not received.Reviews of product design and manufacturing documentation did not reveal any recent changes made to the design, materials, or manufacturing processes of the powertrialysis acute dialysis catheter product line.This evaluation will be updated if additional information becomes available.
Event or Problem Description
Customer inquired on any changes in design or manufacturing process for device.Additional information received 11/6/2023: it was reported by the customer "the two ports and their respective lines leading to the "y" hub (arterial and venous) became detached from the hub.This was a 79 year old white male patient weighing 77kg with a pmh significant for leukemia and gi neuroendocrine tumor who presented with weakness and encephalopathy.He developed aki which required dialysis with catheter in question.The patient coded requiring acls and the patient expired." additional information received 11/30/2023: it was reported by the customer ¿the patient was noted to have been resting comfortably prior to the code.He did have dialysis earlier in the day ~ 8 hours prior to code.The two ports and their respective lines leading to the "y" hub (arterial and venous) became detached from the hub.Cause of death was exsanguination from detachment of the dialysis catheter.Code efforts rendered immediately upon loss of pulses.Rosc not achieved.Device was noted to have been working properly, site was clean, dry, and intact.It was noted that a tegaderm was not being used at the time of the event and ports were clamped.¿.

• Brand Name: POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS
• Common Device Name: 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18229401
• Report Number: 3006260740-2023-05397
• Device Sequence Number: 17692916
• Product Code: NIE
• UDI-Device Identifier: 00801741075094
• UDI-Public: (01)00801741075094
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 02/14/2024

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 Model Number: N/A
• Device Catalogue Number: 5615150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 11/30/2023; 02/14/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/02/2023; 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Death
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: White