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U.S. Department of Health and Human Services

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

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ANGIODYNAMICS SCHON XL DOUBLELUMEN CATHETER; SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS Back to Search Results
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).
 
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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 Key6618906
MDR Text Key76884910
Report Number1319211-2017-00061
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K971925
Number of Events Reported1
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 Manufacturer06/26/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/19/2017
Initial Date FDA Received06/07/2017
Supplement Dates Manufacturer Received05/19/2017
Supplement Dates FDA Received11/29/2017
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 Number1
Patient Outcome(s) Required Intervention;
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