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

Catalog Number 6393190

Device Problems Corroded (1131); Material Discolored (1170); Material Opacification (1426); Stretched (1601); Material Deformation (2976); Material Protrusion/Extrusion (2979)

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

Event Date 11/26/2021

Event Type  malfunction  

Event Description

It was reported that eight months post dialysis catheter placement, the catheter was allegedly noted to be discoloured and corroded.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records was performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 05/2021).

Event Description

It was reported that eight months post dialysis catheter placement, the catheter was allegedly noted to be discolored and corroded.It was further reported that the device was removed.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 19cm glidepath d/l catheter was returned for evaluation.Gross visual and functional evaluation.The investigation is confirmed for the identified material opacification and material deformation issues as both the extension legs appeared emulsified and a bulge was noted on the venous extension leg just distal to the bifurcation.Further the catheter was noted to be flattened.However, the investigation is unconfirmed for the reported catheter discoloration and corrosion issues as no objective evidence related to the reported event was noted on the catheter.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: b5, d4 (expiry date: 05/2021).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.

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 19cm glidepath d/l catheter was returned for evaluation.Gross visual and functional evaluation.The investigation is confirmed for the identified material opacification, material deformation and stretched issues as both the extension legs appeared to be in a milky white color and a bulge was noted on the venous extension leg just distal to the bifurcation.However, the investigation is unconfirmed for the reported catheter discoloration and corrosion issues as no objective evidence related to the reported event was noted on the catheter.A definitive root cause could not be determined based upon the 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.D4 (expiry date: 05/2022).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 approximately eight months post dialysis catheter placement, the catheter was allegedly noted to be discolored and corroded.It was further reported that the device was removed.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: 13058157
• MDR Text Key: 282605822
• Report Number: 3006260740-2021-05382
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741138492
• UDI-Public: (01)00801741138492
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 06/01/2022

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: 6393190
• Device Lot Number: REDU2651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 12/27/2021; 06/13/2022
• Supplement Dates FDA Received: 12/29/2021; 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2019
• 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 Age: 53 YR
• Patient Sex: Female