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

Catalog Number	1080170
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
(2nd device/event).An end user reported an issue with a temporary, non-tunneled 14f x 15cm basic schon catheter.The patient had the catheter placed on (b)(6) 2020, however, after several minutes of treatment, blood was noted to be dripping from the arterial port of the catheter.A pinprick sized hole was discovered.The patient required replacement of the catheter the following day, on (b)(6) 2020.When the patient returned for treatment on (b)(6) 2020, blood was found to be leaking again, except from the venous port.A small slit was discovered in the catheter line.The patient then had to have a 3rd catheter placed.It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint of a hole in extension leg tubing near arterial port could not be confirmed as no sample was returned or photographic evidence was provided.Without receiving product sample for evaluation, a root cause of this event cannot be determined.(b)(6) was sent to the device manufacturer for dhr review of reported device lot number.See scar response for details.Per supplier: "no samples nor pictures were provided for failure mode evaluation and root cause analysis; therefore, the customer complaint cannot be fully analyzed to confirm the existence of the reported failure mode; regardless that fact, an investigation will be conducted based on complaint description provided by customer." 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, which is supplied to the end user with states; "clamping the catheter repeatedly in the same spot could weaken the tubing.Change the position of the clamps regularly to prolong the life of the tubing." a review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: SCHON XL DIALYSIS CATHETER
• Common Device Name: SCHON¿ HEMODIALYSIS DIALYSIS CATHETER SETS
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 10572738
• Report Number: 1319211-2020-00061
• Device Sequence Number: 19601431
• Product Code: MSD
• UDI-Device Identifier: H787108017015
• UDI-Public: H787108017015
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K971925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2024
• Device Catalogue Number: 1080170
• Device Lot Number: MNRL670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1