MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO DIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number 10302820

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/20/2020

Event Type  malfunction  

Manufacturer Narrative

As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description cannot be confirmed, no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: the directions for use (dfu) that is provided in the reported kit contains the following directions, precautions and warnings: warning contents supplied sterile using an ethylene oxide (eo) process.Do not use if sterile barrier is damaged.If damage is found, call your sales representative.Inspect prior to use to verify that no damage has occurred during shipping.For single patient use only.Do not reuse, reprocess or resterilize.Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death.Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.Contamination of the device may lead to injury, illness or death of the patient.Precaution: always review hospital or unit protocol, potential complications and their treatment, warnings, and precautions prior to catheter removal.Palpate the catheter exit tunnel to locate the cuff.2.Administer sufficient local anesthetic to exit site and cuff location to completely anesthetize the area.Cut sutures from suture wing.Follow hospital protocol for removal of skin sutures.4.Make a 2 cm incision over the cuff, parallel to the catheter.5.Dissect down to the cuff using blunt and sharp dissection as indicated.6.When visible, grasp cuff with clamp.7.Clamp catheter between the cuff and the insertion site.8.Cut catheter between cuff and exit site.Withdraw internal portion of catheter through the incision in the tunnel.9.Remove remaining section of catheter (i.E.Portion in tunnel) through the exit site.Precaution: do not pull distal end of catheter through incision as contamination of wound may occur.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).

Event Description

An assistant nurse manager reported that when the bioflo duramax catheter was being removed, the cuff came off in the patient.The cuff was left in the patient's chest and there are currently no plans to remove it.The patient had the catheter in for 1 month.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.It was reported the defective disposable device is not available for return to the manufacturer.

• Brand Name: BIOFLO DIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, ny ; 7424488
• MDR Report Key: 10052306
• MDR Text Key: 198935735
• Report Number: 1317056-2020-00084
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: H965103028201
• UDI-Public: H965103028201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 10302820
• Device Lot Number: 5272022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• 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: 45 YR