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

Catalog Number 6393230

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562); Migration (4003)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2023

Event Type  malfunction  

Event Description

It was reported that sometime post a dialysis catheter placement, the catheter allegedly had a leak from the extension line below the hub.It was further reported that the breakage happened at the extension line below the hub.It was also reported that the catheter allegedly migrated towards the heart.Reportedly, the catheter was removed and replaced.There was no reported patient injury.

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, video was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 05/2024).H11: 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.H3 other text : device pending return.

Event Description

It was reported that sometime post a dialysis catheter placement, the catheter allegedly had a leak from the extension line below the hub.It was further reported that the breakage happened at the extension line below the hub.Reportedly, the catheter was removed and replaced.There was no reported patient injury.

Manufacturer Narrative

H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as malfunction.H10: 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.However, a video was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 05/2024), g3 h11: 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 Description

It was reported that sometime post a dialysis catheter placement, the catheter allegedly had a leak from the extension line below the hub.It was further reported that the breakage happened at the extension line below the hub.Reportedly, the catheter was removed and replaced.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one glidepath d/l 23cm catheter and one video were received for evaluation.Visual, microscopic and functional evaluations was performed.The distal catheter segment was not returned.A partial circumferential break was noted to the distal end of the red luer where hub meets.In the video, the clinician was holding an implanted catheter which was noted to have a crack in the bifurcation area and blood was noted to be leaking from the connection area of the bifurcation site and the extension leg.Therefore the investigation is confirmed for the reported fracture and fluid leak issues.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.H10: d4 (expiry date: 05/2024), g3, h2, h6 (method).H11: h6 (result, conclusion).H11: 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.H3 other text : see h10.

• Brand Name: GLIDEPATH
• Type of Device: 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: 17265312
• MDR Text Key: 318440191
• Report Number: 3006260740-2023-02793
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741138508
• UDI-Public: (01)00801741138508
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 6393230
• Device Lot Number: REGU2544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 09/13/2023; 10/26/2023
• Supplement Dates FDA Received: 09/28/2023; 10/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention