MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNKNOWN GLIDEPATH; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number UNK GLIDEPATH

Device Problems Fluid/Blood Leak (1250); Failure to Infuse (2340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records or medical images have been made available to the manufacturer.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.The information provided by bard 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 bard.

Event Description

It was reported that the device stopped functioning properly approximately one day after placement.The device was removed and replaced.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be performed, as the lot number is unknown.Investigation summary: one unknown glidepath hemodialysis catheter was returned for evaluation.Visual inspection identified a partial circumferential split just distal to the cut on the catheter.The type of split could not be identified, therefore, the investigation is confirmed for a subcutaneous leak without embolism.The definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

Event Description

It was reported that the device stopped functioning properly approximately one day after placement.The device was removed and replaced.There was no reported patient injury.

• Brand Name: UNKNOWN GLIDEPATH
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7912693
• MDR Text Key: 122110639
• Report Number: 3006260740-2018-02609
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK GLIDEPATH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR