MAUDE Adverse Event Report: ANGIODYNAMICS SCHON XL DOUBLELUMEN CATHETER; SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS

Device Problem Hole In Material (1293)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/16/2017

Event Type  Injury  

Manufacturer Narrative

Angiodynamics notified the dialysis catheter manufacturer of this complaint event on may 23, 2017 via supplier corrective action request (b)(4).As part of a review of complaints related to distribution only products, angiodynamics identified that it does not have objective evidence that the manufacturer assessed this complaint event for mdr reportability.As a result of this review, angiodynamics chose to assess this complaint event for reportability and determined that it does meet the criteria to file an mdr.This retrospective mdr is being filed based on this review and to ensure complaint file is complete.It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation.To date the device has yet to be returned.Attempts are being made to obtain the device.An investigation into the root cause for incident is currently in progress.The results of the investigation will be sent via a follow up medwatch.Complaint reference (b)(4).Device not received to date.

Event Description

As reported to angiodynamics on may 19, 2017: schon xl placed in or (b)(6) 2017.Event occurred (b)(6) 2017 approx 4am.At 04:00 nurse was changing patient's dressings including her central line dressings.The central lines she has in are both an arterial and a cvvh line in her right femoral.While removing the dressing (no scissors involved, simply peeling back tape), blood gushed from what i thought was the site.Nurse held pressure and examined the patient, finding that the blood was actually coming through the venous tubing of her cvvh line.Patient is on ecmo.Ecmo rn saw entire incident and assisted me in clamping the tubing.Appears as if a piece of tubing was missing, piece of tubing was sheared off, and/or piece of tubing was squeezed into another piece at site-equipment malfunction (?).Pa sitting outside of door, immediately called to scene along with dialysis tech.Tubing clamp stayed on, sterile dressing and cap applied to open site.It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

One schon dialysis catheter was returned for evaluation.The device was forwarded to angiodynamics' vendor for of this device for evaluation.Therefore, an internal investigation was not completed.Per (b)(4) vendor response, the supplier states that they do not manufacture this device.The catheter is extruded by their supplier and then assembled at their manufacturing facility.Their supplier has been notified of this event, however, no further information was received from angiodynamics' supplier as to the device evaluation conclusion and a root cause determination.Multiple attempts have been made to angiodynamics supplier to obtain this information, however, the supplier has been unresponsive.The incoming receiver lot record indicate that all device specification and quality requirements were met.Angiodynamics is the distributor for this product.This device is not made at the angiodynamics facility.It is noted that the event outside the patient and no harm or injury was reported.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.The instructions for use, which is supplied to the end user with this catalog number, states: "there is a potential for product failure related to the use of ointments on catheters.Do not use ointments of any kind.Do not use iodine or iodine based solutions on this catheter.Failure of catheter will occur.Alcohol based solutions are recommended as the antiseptic solution that can be used on this catheter." 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.Complaint # (b)(4).

• Brand Name: SCHON XL DOUBLELUMEN CATHETER
• Type of Device: SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law law ryan ; 603 queensbury avenue; queensbury, NY 12804 ; 5187424488
• MDR Report Key: 6618906
• MDR Text Key: 76884910
• Report Number: 1319211-2017-00061
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

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: Nurse
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2017
• Initial Date FDA Received: 06/07/2017
• Supplement Dates Manufacturer Received: 05/19/2017
• Supplement Dates FDA Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention