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

Catalog Number	5393230
Medical Device Problem Codes	Complete Blockage (1094); Coagulation in Device or Device Ingredient (1096); Entrapment of Device (1212); Nonstandard Device (1420); Defective Component (2292); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
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 placement procedure of glidepath dialysis catheter via right internal jugular vein.During the procedure, it was reported that the dilator was allegedly did not have a hollow space for the guidewire to pass through.It was further reported that the dilator was stuck inside the patient.The procedure was completed by using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one 12fr dilator was returned for evaluation.Visual, microscopic visual and functional evaluations were performed.The distal tip of the dilator was noted to not have an exit port as it noted to be sealed.Guidewire was inserted into the dilator, and the guidewire did not protrude the distal end as blockage was felt.A portion of the distal end of the dilator was cut for further evaluation, and adhesive was noted within the distal portion and sealing the exit port.Manufacturing review was performed and closer view revealed a complete occlusion of the distal tip of the dilator.In the functional tests it was observed that an attempt was made to pass a guide wire through the dilator, but it did not come out of the tip.The manufacturing reviewed confirmed the "occluded dilator" and the process indicated that this defect is related to the tip forming process, the lack of verification of the passage of the guide wire is a potential cause.Therefore, the investigation is confirmed for the reported dilator does not have a hollow space issue identified coagulation of adhesive and complete blockage issues.However, the investigation is inconclusive for the reported dilator stuck inside the patient issue as the exact circumstances at the time of the reported event cannot be verified from the returned physical sample.The root cause was determined to be manufacturing related.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (unique identifier (udi)), 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.
Event or Problem Description
On (b)(6) 2025 a patient underwent a placement procedure of glidepath dialysis catheter via right internal jugular vein.During the procedure, it was reported that the dilator was allegedly did not have a hollow space for the guidewire to pass through.It was further reported that the dilator was stuck inside the patient.The procedure was completed by using another device.There was no reported patient injury.

• 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: 23243023
• Report Number: 3006260740-2025-07543
• Device Sequence Number: 10414350
• Product Code: MSD
• UDI-Device Identifier: 00801741012181
• UDI-Public: (01)00801741012181(11)250422(17)270131(10)REKQ2521
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2026

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 Catalogue Number: 5393230
• Device Lot Number: REKQ2521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 03/31/2026; 06/04/2026
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 04/02/2026; 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2025
• 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
• Patient Sex: Unknown