MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SOFT CELL PC-2 DIALYSIS CATHETER KIT, 12.5F

Catalog Number	5534190
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Sepsis (2067)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two years post a dialysis catheter placement, the patient allegedly experienced blood leaking out of the exit port.It was further reported that the patient was allegedly hospitalized due to sepsis.Reportedly, the cuff was allegedly found to be damaged, and the blood would come out of the cuff for both the artery side and vein side.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be 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 two years post a dialysis catheter placement, the patient allegedly experienced blood leaking out of the exit port.It was further reported that the patient was allegedly hospitalized due to sepsis.Reportedly, the cuff was allegedly found to be damaged, and the blood would come out of the cuff for both the artery side and vein side.The current status of the patient is unknown.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one 19 cm soft cell d/l catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.The tissue cuff appeared detached on one end.What appeared to be a partial circumferential break was noted between the catheter body and the tissue cuff.The edges of the complete circumferential break on the distal end of the catheter were noted to be uneven, a leak was observed exiting the partial circumferential break at the tissue cuff.Therefore, the investigation is confirmed for the reported fracture, fluid leak and identified naturally worn and deformation issue.Furthermore, clinical conditions alleged in the complaint cannot be confirmed.The identified break is typical of flexural fatigue.Although a definitive root cause could not be determined, flexural fatigue (repeated/cyclic kinking of the catheter which can cause gradual tearing in the catheter) could have potentially caused or contributed to the reported event.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (device, component, method, result, conclusion).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.

• Brand Name: SOFT CELL PC-2 DIALYSIS CATHETER KIT, 12.5F
• 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: 21510863
• Report Number: 3006260740-2025-01158
• Device Sequence Number: 12764151
• Product Code: LFJ
• UDI-Device Identifier: 00801741012440
• UDI-Public: (01)00801741012440
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2025

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 Catalogue Number: 5534190
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 06/19/2025
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 14 YR
• Patient Sex: Female