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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIODYNAMICS, INC SCHON XL DOUBLE LUMEN CATHETER 20CM; SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS,

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ANGIODYNAMICS, INC SCHON XL DOUBLE LUMEN CATHETER 20CM; SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS, Back to Search Results
Catalog Number H787108007025
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/03/2019
Event Type  malfunction  
Manufacturer Narrative
Angiodynamics has notified the schon dialysis catheter manufacturer of this complaint event.The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Complaint # (b)(4).
 
Event Description
As reported: we placed a schon xl non-tunneled catheter today.It aspirated and flushed with no issue.Patient was sent to the main hospital to collect stem cells.While there, the hub of the catheter was bubbling; a sign of air being aspirated.A crack in the hub was suspected, and the patient was brought back for a catheter exchange.The patient suffered no harm or injury due to this event.The reported defective disposable device has been returned to the manufacturer for evaluation.
 
Manufacturer Narrative
Returned for evaluation was a 20cm schon xl dialysisi catheter.A crack was observed when a syringe with water was attached, when flushed it was then noted water coming from the blue hub (venous luer).The customer's complaint description is confirmed.The device was forwarded to angiodynamics' supplier of this product for evaluation, root cause determination and corrective action.Supplier stated: "multiple pictures under magnification were provided by the customer for evaluation, all of them clearly shows a crack located in the venous luer.Therefore, the reported failure mode is confirmed".Although the complaint description is confirmed, 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.The instructions for use, which is supplied to the end user, states; "it is recommended that only luer lock (threaded) connections be used with this catheter (including syringes, bloodlines, iv tubing and injection caps).Repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure.Inspect the catheter frequently for nicks, scrapes, cuts, etc.Which could impair it performance." 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 DOUBLE LUMEN CATHETER 20CM
Type of Device
SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS,
Manufacturer (Section D)
ANGIODYNAMICS, INC
603 queensbury avenue
queensbury NY 12804
MDR Report Key9124786
MDR Text Key160360357
Report Number1319211-2019-00089
Device Sequence Number1
Product Code MSD
UDI-Device IdentifierH787108007025
UDI-PublicH787108007025
Combination Product (y/n)N
PMA/PMN Number
K971925
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 11/27/2019
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 Expiration Date10/28/2021
Device Catalogue NumberH787108007025
Device Lot NumberMNLN680
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2019
Initial Date Manufacturer Received 09/03/2019
Initial Date FDA Received09/26/2019
Supplement Dates Manufacturer Received09/03/2019
Supplement Dates FDA Received11/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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