MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATH HEMODIALYSIS CATHETER; LONG-TERM HEMODIALYSIS CATHETER

Catalog Number 6393190

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a manufacturing review cannot be performed as the batch/lot number were not provided.Investigation summary: a sample evaluation could not be performed as the samples were not returned.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Possible contributing factors include insufficient attachment mechanism between the tunneler and the catheter / incorrect tunneler /catheter interface, clinician error; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).The investigation is inconclusive due to the fact that no sample was returned for evaluation.Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.

Event Description

It was reported that sometime after placement of the dialysis catheter, the catheter allegedly dislodged.It was further reported the device was removed and replaced.There was no reported patient injury.

• Brand Name: GLIDEPATH HEMODIALYSIS CATHETER
• Type of Device: LONG-TERM HEMODIALYSIS 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8735320
• MDR Text Key: 149232169
• Report Number: 3006260740-2019-01765
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741121753
• UDI-Public: (01)00801741121753
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 06/25/2019

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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