MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER-TRIALYSIS SLIM-CATH STRAIGHT ST DIALYSIS CATHETER (12F) (TL) (24CM); CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
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 device has not been returned to the manufacturer for evaluation, as the device remains in the patient.
Event or Problem Description
It was reported on 7/09/2024, we had a triple lumen bard central line-purple lumen clamp broken bard lot # rehs3822 placed on (b)(6) 2023.The defective bard catheter is still on the patient, he is not done with treatment.The broken clamp was a safety issue only and has not interrupted the patient's treatment.We have attached a replacement clamp.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 a broken clamp is confirmed, but the root cause could not be determined.One photo was returned for evaluation.The photo shows the extension tubing and luer hub of a triple lumen dialysis catheter.The catheter appears to be indwelling in the patient as adhesive dressing can be seen securing the catheter to the chest of the patient.Inspection of the clamps found that the purple clamp was broken on one side of the clamp latch.An external red clamp is present and engaged distal of the purple clamp on the same extension tubing leg.Multiple kinks can be seen on the purple extension tubing, indicating that the purple clamp or external red clamp have been actuated multiple times.No other damage can be seen on the purple clamp.Based on the available material for review, there were no distinguishing features in the returned photo which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported on (b)(6) 2024, we had a triple lumen bard central line-purple lumen clamp broken bard lot # rehs3822 placed on (b)(6) 2023.The defective bard catheter is still on the patient, he is not done with treatment.The broken clamp was a safety issue only and has not interrupted the patient's treatment.We have attached a replacement clamp.No other information was provided.

• Brand Name: POWER-TRIALYSIS SLIM-CATH STRAIGHT ST DIALYSIS CATHETER (12F) (TL) (24CM)
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20053754
• Report Number: 3006260740-2024-04684
• Device Sequence Number: 15427957
• Product Code: NIE
• UDI-Device Identifier: 00801741107177
• UDI-Public: (01)00801741107177(11)230705(17)241031(10)REHS3822
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 5855240
• Device Lot Number: REHS3822
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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: Other
• Patient Sex: Unknown