MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DECATHLON DF LONG-TERM HEMODIALYSIS CATHETER

Catalog Number	DF19IT24K
Medical Device Problem Codes	Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
Event or Problem Description
It was reported that during a preparation of dialysis placement procedure in the right internal jugular vein for hemodialysis access, the catheter was allegedly kinked.It was further reported that the device allegedly failed to advance over the wire.The procedure was completed using same device.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one 19cm decathlon d/l catheter was return for sample evaluations.Visual and functional evaluations were performed.The stylet was loaded onto the red luer.A kink was noted to the proximal end of the stylet.Distinct curvature was noted throughout the catheter.An attempt to load an in-house j-tip guidewire into the loaded catheter stylet was performed and was unsuccessful.Resistance was felt during attempt.The catheter stylet was removed for further observation.The guidewire was noted to be stuck in the center portion of the catheter stylet.The loaded in-house j-tip guidewire was removed from the catheter stylet.Resistance was felt.Therefore, the investigation is confirmed for the reported kink and advancement difficulty.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f: the information provide by bd represents all 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.
Event or Problem Description
It was reported that during a preparation of dialysis placement procedure in the right internal jugular vein for hemodialysis access, the catheter was allegedly kinked.It was further reported that the device allegedly failed to advance over the wire.The procedure was completed using same device.There was no patient contact.

• Brand Name: DECATHLON DF LONG-TERM HEMODIALYSIS CATHETER
• Common Device Name: 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 20681428
• Report Number: 3006260740-2024-06645
• Device Sequence Number: 8583993
• Product Code: MSD
• UDI-Device Identifier: 00801741013935
• UDI-Public: (01)00801741013935(17)260131(10)REJP3283
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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: 01/31/2026
• Device Catalogue Number: DF19IT24K
• Device Lot Number: REJP3283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 01/07/2025
• 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
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 86 KG