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U.S. Department of Health and Human Services

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

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ANGIODYNAMICS, INC SCHON XL DOUBLELUMEN CATHETER; SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS, Back to Search Results
Catalog Number H787108007025
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/03/2019
Event Type  malfunction  
Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
 
Event Description
Device #1.As reported: (b)(6) said the catheter was leaking under the hub.Two devices had the same issue, both had the same lot number and upn number.Both were used on the same patient.Both catheters were replaced, the second defective catheter was replaced with a 24cm rather than a 20cm.It was reported the defective disposable device is not available for return to the manufacturer as it was disposed of by the user.
 
Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.A photo of the cracked hub was provided for evaluation.The customer's reported complaint description cannot be confirmed due to the sample not being returned although a photo was provided.A definitive root cause for the hub crack cannot be determined.Angiodynamics' supplier of this device was notified of the event.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 instructions for use (ic 147), which is supplied to the end user with 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 DOUBLELUMEN CATHETER
Type of Device
SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS,
Manufacturer (Section D)
ANGIODYNAMICS, INC
603 queensbury avenue
queensbury, ny NY 12804
MDR Report Key9315197
MDR Text Key167438896
Report Number1319211-2019-00104
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 company representative,health
Type of Report Initial,Followup
Report Date 02/24/2020
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 Expiration Date10/25/2021
Device Catalogue NumberH787108007025
Device Lot NumberMNGT420
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/31/2019
Initial Date FDA Received11/13/2019
Supplement Dates Manufacturer Received10/31/2019
Supplement Dates FDA Received02/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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