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

Model Number 5393270

Device Problems Stretched (1601); Deformation Due to Compressive Stress (2889); Material Protrusion/Extrusion (2979)

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

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one 27cm glidepath d/l catheter was returned for evaluation.Gross visual, tactile and functional evaluation were performed on the returned device.The investigation is confirmed for the reported stretched and identified protrusion issues as ballooning was noted on the blue extension leg of the catheter just distal to the hub.The investigation is also confirmed for the identified deformation issue as a kink was noted on the red extension leg of 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.

Event Description

It was reported that some time post dialysis catheter placement through the right internal jugular vein, the venous port of the catheter allegedly appeared to be stretched due to a pull or being under pressure.It was further reported that catheter was removed from the patient.The procedure was completed using another device.There was no reported patient injury.

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12878099
• MDR Text Key: 281318930
• Report Number: 3006260740-2021-05038
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741012198
• UDI-Public: (01)00801741012198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2021

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 Model Number: 5393270
• Device Catalogue Number: 5393270
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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: 52 YR
• Patient Sex: Male