MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GLIDEPATH; DIALYSIS CATHETER

Catalog Number	5393230
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/01/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
H11: 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.Section a through f ¿ the information provided 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
On (b)(6) 2025, a patient underwent a bd glidepath dialysis catheter placement procedure for dialysis treatment.On (b)(6) 2025, it was reported during a dialysis session, the venous-side luer connector allegedly detached from the dialysis circuit while the circuit was being rotated, resulting in a significant blood loss.Reportedly, there was no visible damage to the venous side luer connector.The incident was discovered during a staff lunch changeover, and the patient subsequently passed away.The hospital believes the disconnection may have been due to an insecure connection, likely a procedural issue.The patient's cause of death was unknown.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one glidepath d/l catheter and a stopcock were returned for evaluation.A visual inspection was performed on the returned device.The complaint sample appeared to have blood residue throughout, and no caps were present on the luers.The catheter was returned with both clamps engaged.The luers on the catheter and the stopcock were thoroughly inspected.No unusual findings were observed on the exterior or interior of the luer hubs and the stopcock.The luer threads appeared normal on both hubs.During functional testing, an in-house syringe was attached to both luers without issue, and no leaks were observed from either luer or along the catheter.Additionally, the unknown brand stopcock successfully loaded and locked onto each catheter luer without issue.Functional testing with the stopcock confirmed patency and no leaks during infusion and aspiration via both the blue and red luers.Hydrostatic pressure testing also revealed no leaks throughout the catheter.No medical records were provided.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.Therefore, the reported disconnection and blood leak cannot be confirmed.No causal relationship between the disconnection, blood leak, and the patient¿s death has been established.Based on the available information, the definitive root cause of the disconnection, blood leak, and patient death is unknown.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.D4 (unique identifier (udi) #), g3, h6 (component, method, result, conclusion).Section a through f ¿ the information provided 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
On (b)(6) 2025, a patient underwent a bd glidepath dialysis catheter placement procedure for dialysis treatment.On (b)(6) 2025, it was reported during a dialysis session, the venous-side luer connector allegedly detached from the dialysis circuit while the circuit was being rotated, resulting in a significant blood loss.Reportedly, there was no visible damage to the venous side luer connector.The incident was discovered during a staff lunch changeover, and the patient subsequently passed away.The hospital believes the disconnection may have been due to an insecure connection, likely a procedural issue.The patient's cause of death was unknown.

• Brand Name: GLIDEPATH
• 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: 22910677
• Report Number: 3006260740-2025-06333
• Device Sequence Number: 18405820
• Product Code: MSD
• UDI-Device Identifier: 00801741012181
• UDI-Public: (01)00801741012181(11)250228(17)261130(10)REKN1646
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: 5393230
• Device Lot Number: REKN1646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• 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 Sex: Unknown