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

Catalog Number	5303100
Medical Device Problem Codes	Fracture (1260); Loose or Intermittent Connection (1371); Air/Gas in Device (4062)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a dialysis placement procedure using the glidepath hemodialysis catheter.Post the procedure the catheter was allegedly ruptured.There was no reported patient injury.
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 not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.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), a patient underwent a dialysis catheter placement procedure using a glidepath hemodialysis catheter.On (b)(6) 2025, following initiation of dialysis treatment, the presence of air bubbles was observed in the hemodialysis circuit, specifically in the red line connected to the blue lumen of the glidepath catheter.No visible fissures were initially identified, as the suspected break was located beneath the patient's tegaderm dressing.The catheter was later found to be ruptured at the junction between the outer catheter tubing and the plastic hub.The patient was transferred to interventional radiology for an emergency evaluation of the dialysis line.After the dialysis line was changed and the defective catheter was retrieved, the catheter break was confirmed.The current status of the patient was unknown.
Additional Manufacturer Narrative
H11: additional information was received through follow up, and the complaint was reassessed for reportability.Based on the updated information indicating that the catheter was removed by interventional radiology, the event was determined to be reportable as a serious injury.Manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one 10cm d/l glide path catheter was returned for sample evaluation.Along with return sample one photo was provided for the review.Visual, microscopic visual, tactile and functional evaluations were performed.A partial circumferential break was noted on the distal end of red luer extension leg.The edges of break on the was noted to be jagged and surface was noted to be granular.No evidence indicating loose fitting was noted near the tissue cuff.Hydrostatic pressure test was performed, and bubbles were noted within the red luer extension leg during testing.Partial break was noted in photo review.Therefore, the investigation is confirmed for the reported fracture and air in device issue.However, the investigation is unconfirmed for the reported loose connections issue as the sample evaluation results indicating no difficulty/issue during testing.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.B1, b2, b3, b5, g3, h1, h6 (patient, 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: 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: 23551408
• Report Number: 3006260740-2025-08649
• Device Sequence Number: 9283632
• Product Code: MSD
• UDI-Device Identifier: 00801741187285
• UDI-Public: (01)00801741187285(11)231028(17)240930(10)REHU3238
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K200627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 03/12/2026

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 Expiration Date: 09/30/2024
• Device Catalogue Number: 5303100
• Device Lot Number: REHU3238
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2023
• 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: Required Intervention
• Patient Sex: Unknown