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

Catalog Number 6393230

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/22/2023

Event Type  malfunction  

Event Description

It was reported that one month and ten days post dialysis catheter placement procedure, the catheter allegedly leaked in extension line below the hub.It was further reported that the extension line was allegedly completely torn and separated from the catheter.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 record is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2024).H11: section a through f - the information provided by bd represents all of 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 : device pending return.

Event Description

It was reported that one month and ten days post dialysis catheter placement, the catheter allegedly leaked in extension line below the hub.It was further reported that the extension line was allegedly completely torn and separated from the catheter.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 23cm glidepath d/l catheter was received for evaluation and one electronic photo was provided for review.Visual, microscopic and functional evaluations was performed.A complete circumferential break was noted to the extension leg of the blue luer, proximal to the clamp.The proximal end of the blue luer extension leg was not received.The edges of the complete circumferential break of the blue luer extension leg were noted to be jagged and the surface was noted to be granular.Therefore, the investigation is confirmed for the reported fracture and material separation issues and the photo review also confirms the same.However the investigation is inconclusive for the reported fluid leak issue as no objective evidence of leak was provided for review.The definitive root cause could not be determined based upon available information.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.H10: d4 (expiry date: (b)(6) 2024), g3 h11: h6 (method, result, conclusion) h11: section a through f - the information provided by bd represents all of 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.

Manufacturer Narrative

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 23cm glidepath d/l catheter was received for evaluation and one electronic photo was provided for review.Visual, microscopic and functional evaluations was performed.A complete circumferential break was noted to the extension leg of the blue luer, proximal to the clamp.The proximal end of the blue luer extension leg was not received.The edges of the complete circumferential break of the blue luer extension leg were noted to be jagged and the surface was noted to be granular.Dry contrast was also noted throughout the break.Therefore, the investigation is confirmed for the reported fracture, fluid leak and material separation issues and the photo review also confirms the same.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.(expiration date: 07/2024) 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 Description

It was reported that one month and ten days post dialysis catheter placement, the catheter allegedly leaked in extension line below the hub.It was further reported that the extension line was allegedly completely torn and separated from the catheter.Reportedly, the catheter was removed and replaced.There was no reported patient injury.

• Brand Name: GLIDEPATH HEMODIALYSIS CATHETER
• 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: 17142249
• MDR Text Key: 317306098
• Report Number: 3006260740-2023-02475
• 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: 11/08/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 6393230
• Device Lot Number: REGW0178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 08/24/2023; 11/08/2023
• Supplement Dates FDA Received: 08/26/2023; 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2022
• 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