MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT, 14.5 FR, ST, 23CM, STAND KIT; DIALYSIS CATHETER

Model Number 5733730

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 07/2019).

Event Description

It was reported approximately five months post dialysis catheter placement in the internal jugular vein that the catheter dislodged.It was further reported that the catheter was removed and replaced.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: manufacturing records were reviewed and there were not found evidence that the failure mode reported in this complaint is caused by the manufacturing process.Investigation summary: one 14.5 fr d/l hemosplit 23 cm str hemodialysis catheter with surecuff and one electronic photo were returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is inconclusive for catheter dislodgement due to tissue in-growth problem, as no obvious abnormalities in the returned sample were discovered during visual observation.Although, in the photo provided, the cuff is located outside of the patient, the portion of the catheter distal to the cuff did not appear to have any blood or tissue residue on the surface.The detailed examination showed the cuff to be stable and not moving on the catheter under manual manipulation.Blood and fluid residue could be observed on the sample and on the catheter cuff.A substantial amount of blood residue can be observed on a localized region on the cuff; however, the remaining portion of the cuff appeared to have little blood residue.The conditions at the time of the reported event could not be reproduced in the lab.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.(expiry date: 07/2019).

Event Description

It was reported approximately five months post dialysis catheter placement in the internal jugular vein that the catheter dislodged.It was further reported that the catheter was removed and replaced.There was no reported patient injury.

• Brand Name: HEMOSPLIT, 14.5 FR, ST, 23CM, STAND KIT
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8708255
• MDR Text Key: 148330314
• Report Number: 3006260740-2019-01679
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741000454
• UDI-Public: (01)00801741000454
• Combination Product (y/n): N
• PMA/PMN Number: K030020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

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 Model Number: 5733730
• Device Catalogue Number: 5733730
• Device Lot Number: REBX0573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR