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 No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.The photo review is pending.The investigation is currently underway.

Event Description

It was reported that approximately three months post dialysis catheter placement that the device allegedly dislodged.It was further reported that the device was removed and replaced.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review could not be performed as the lot number was not provided.Investigation summary: a sample evaluation could not be performed as the samples were not returned.However one electronic photo was received.The photo shows one dialysis catheter, with residual blood on it, wrapped within a cotton bandage with the distal end of the catheter up to slightly past the cuff protruding out of the wrapping bandage.The cuff is entirely covered in blood residue and from the photo it is not possible to judge presence of any tissue ingrowth.The investigation is inconclusive for defective/damaged cuff as there is not enough evidence to confirm a product deficiency.Although a definitive root cause could not be determined, no tissue in-growth in the cuff, cuff attachment surface area not sufficient, poor material selection, or excessive force onto the cuff or catheter could have potentially caused or contributed to the reported event.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 approximately three months post dialysis catheter placement, the catheter allegedly dislodged due to failed tissue in-growth.It was further reported that the device was removed and replaced.There was no reported patient injury.

• 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: 8817338
• MDR Text Key: 151916412
• Report Number: 3006260740-2019-02102
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

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: 5733690
• Device Catalogue Number: 5733690
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 09/25/2019
• Supplement Dates FDA Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1