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

Catalog Number	10800701
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the 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
An angiodynamics territory manager reported an issue with a 15cm schon xl double lumen catheter.Three days after the catheter had been placed in the patient's internal jugular, blood droplets were noticed on the catheter extension tubing.Treatment had not yet been given via the catheter.The catheter was removed and replaced with another same device.There was no report of patient harm or adverse event by the end user.It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Correction : box b1; selection had not been made.Selection of product problem was made as a correction.Reference (b)(4).
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint of schon dialysis catheter leaking from the extension leg tubing could not be confirmed as no sample was returned.Without receiving product sample for evaluation, a root cause of this event cannot be determined.Scar004331 was sent to schon dialysis manufacturer and design owner, martech medical, to make them aware of this event and to perform review of dhr for reported lot number.Scar004331 response states, " according to the investigation performed and dhr and process review we can establish that the catheter was manufactured according to established procedures and customer specifications.Current process controls call to perform visual inspections to detect any damage over tip and along the catheter and leak test as a last manufacturing process; therefore, the reported failure mode is considered not associated to point medical west manufacturing processes." a review of the incoming receiver lot record was performed for reported packaging lot mhka480 with catalog number h787108017015 for any deviations related to the reported defect of the complaint.The review confirmed that the incoming lot met all material, assembly, and performance specification.Labeling review: the instructions for use, which is supplied to the end user with this catalog number, 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: 11797126
• Report Number: 1319211-2021-00036
• Device Sequence Number: 17105521
• Product Code: MSD
• UDI-Device Identifier: H787108007015
• UDI-Public: H787108007015
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K971925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2021

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: 05/22/2023
• Device Catalogue Number: 10800701
• Device Lot Number: MPDP890
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 04/23/2021; 04/23/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 07/10/2021; 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1