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

Catalog Number	5343230
Medical Device Problem Codes	Fluid/Blood Leak (1250); Obstruction of Flow (2423); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Extravasation (1842); Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: 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.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) 2026, a patient underwent a dialysis catheter placement procedure using glidepath.During the procedure, it was reported that bleeding was observed from the cuff-side exit port immediately upon device clogging.Reportedly, a macroscopic inspection did not reveal any visible tear; however, when a pull-and-push action was applied from the blue side, blood was seen seeping from the tunnel, indicating an internal leak.Furthermore, leakage could not be reproduced without applying considerable force, making it difficult to identify the precise location of the damage.There was no reported patient injury.
Additional Manufacturer Narrative
H11: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.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.B1, b5, h1, h6 (patient).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) 2026, a patient underwent a dialysis catheter placement procedure using glidepath.During the procedure, it was reported that bleeding was observed from the cuff side exit port immediately upon device clogging.Reportedly, a macroscopic inspection did not reveal any visible tear; however, when a pull-and-push action was applied from the blue side, blood was seen seeping from the tunnel, indicating an internal leak.Furthermore, leakage could not be reproduced without applying considerable force, making it difficult to identify the precise location of the damage.It was additionally reported that there was a tendency for subcutaneous bleeding during flushing.The procedure was completed using another device.The current status of the patient was unknown.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: received one 23cm glidepath d/l catheter.The distal catheter segment was not returned.Visual, microscopic, tactile and functional evaluations were performed on the returned device.An in-house syringe was attached to both red luer and blue luer.The catheter was patent to infusion and aspiration.No leaks were observed throughout the catheter.Hydrostatic pressure was applied by clamping the distal end of the catheter while infusing.No leaks were observed throughout the catheter when an in-house syringe with dye water was attached to the red luer and blue luer.The catheter was gently stretched and no evidence indicating loose fitting was noted near the tissue cuff.The tissue cuff was intact.Therefore, the investigation is inconclusive for the reported material integrity, obstruction of flow and fluid leak as the sample evaluation results indicating no difficulty/issue under laboratory conditions may not be representative of the condition of the device during use.A definitive root cause could not be determined based upon the provided information.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (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) 2026, a patient underwent a dialysis catheter placement procedure using glidepath.During the procedure, it was reported that bleeding was observed from the cuff side exit port immediately upon device clogging.Reportedly, a macroscopic inspection did not reveal any visible tear; however, when a pull and push action was applied from the blue side, blood was seen seeping from the tunnel, indicating an internal leak.Furthermore, leakage could not be reproduced without applying considerable force, making it difficult to identify the precise location of the damage.It was additionally reported that there was a tendency for subcutaneous bleeding during flushing.The procedure was completed using another device.The current status of the patient 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: 24243043
• Report Number: 3006260740-2026-00384
• Device Sequence Number: 9971296
• Product Code: MSD
• UDI-Device Identifier: 00801741187407
• UDI-Public: (01)00801741187407
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 03/13/2026

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 Catalogue Number: 5343230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 01/22/2026; 03/13/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 02/13/2026; 03/23/2026
• 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: Required Intervention
• Patient Sex: Female