MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATHHEMODIALYSISCATH; DIALYSIS CATHETER

Catalog Number 6393230

Device Problems Defective Component (2292); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2019

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 04/2021).

Event Description

It was reported that sometime post dialysis catheter placement, the catheter was allegedly dislodged due to failed tissue in-growth on cuff.There was no reported patient injury.

• Brand Name: GLIDEPATHHEMODIALYSISCATH
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9418330
• MDR Text Key: 169314259
• Report Number: 3006260740-2019-03770
• 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: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6393230
• Device Lot Number: REDS4918
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2019
• 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: 46 YR
• Patient Weight: 76