MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT, 14.5 FR, ST, 19CM, STAND KIT; DIALYSIS CATHETER

Model Number 5733690

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

Patient Problem Injury (2348)

Event Date 04/19/2019

Event Type  Injury  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.(expiry date 10/2019).

Event Description

It was reported that approximately two months post catheter placement in the internal jugular vein, the catheter allegedly dislocated as a consequence of failed tissue in-growth around the cuff.Therefore, the catheter was removed and replaced with a new dialysis catheter.The patient was stable at the conclusion of the procedure.

Event Description

It was reported that approximately two months post catheter placement in the internal jugular vein, the catheter allegedly dislocated as a consequence of failed tissue in-growth around the cuff.Therefore, the catheter was removed and replaced with a new dialysis catheter.The patient was stable at the conclusion of the procedure.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 14.5 fr d/l hemosplit 19 cm str hemodialysis catheter with surecuff and two electronic photos were returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.Additionally, a photo review was performed on the photos returned by the complainant.The investigation is inconclusive for catheter dislodgement due to failed tissue ingrowth, 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 clinical circumstances leading up to and at the time of the reported event are unknown and could not be reproduced in the lab.Blood residue was observed throughout the cuff.The definitive root cause could not be determined based upon available information.Physiological, placement and mechanical factors may have contributed to the reported event.However, it is unknown if procedural and/or patient issues contributed to the reported event.The exact circumstances at the time of the event are unknown.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.The following statements from ifu may be helpful.¿for optimal performance, do not insert any portion of the cuff into the vein.¿ ¿position the white retention cuff approximately midway between the skin exit site and the venous entry site, 3 cm minimum, from the venous entry site.¿ ¿catheter removal the white retention cuff facilitates tissue in-growth.The catheter must be surgically removed.Free the cuff from the tissue and pull the catheter gently and smoothly.¿ ¿the exit site should be checked daily.Aseptic technique, including facemasks, for nurse and patient hand washing, and gloves must be used for these procedures.4.Carefully remove the dressing and inspect the exit site for inflammation, swelling and tenderness.Notify physician immediately if signs of infection are present.5.Clean the exit site with an antimicrobial solution following your institution¿s protocol.Clean from the catheter working outward in a circular motion.¿ (expiry date 10/2019).

• Brand Name: HEMOSPLIT, 14.5 FR, ST, 19CM, 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: 8614100
• MDR Text Key: 145228256
• Report Number: 3006260740-2019-01395
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013096
• UDI-Public: (01)00801741013096
• Combination Product (y/n): N
• PMA/PMN Number: K030020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5733690
• Device Catalogue Number: 5733690
• Device Lot Number: RECS1670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Manufacturer Received: 04/19/2019
• Initial Date FDA Received: 05/15/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR