MAUDE Adverse Event Report: MEDCOMP 10F X 24CM SPLIT CATH; SPLIT CATH XL HEMODIALYSIS CATHETER

Model Number	ASPC24P-XL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Renal Failure (2041); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated.Additional information and the sample have been requested.
Event or Problem Description
Tunneled hemodialysis catheter was noted as having problems with flow during dialysis sessions so the renal team asked that it be removed.The catheter was removed successfully at the bedside.However, a foreign body of the chest wall was noted after the removal.Patient was transferred to the sedation area where a single piece of opaque white plastic tubing, consistent with hemodialysis catheter, was removed.
Additional Manufacturer Narrative
Attempts to obtain additional information and the sample for evaluation were unsuccessful.Without sufficient information, or an evaluation of the device involved, we are unable to determine the cause or factors that may have contributed to this event.

• Brand Name: 10F X 24CM SPLIT CATH
• Common Device Name: SPLIT CATH XL HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8909784
• Report Number: 2518902-2019-00055
• Device Sequence Number: 372058
• Product Code: MSD
• UDI-Device Identifier: 00884908003581
• UDI-Public: 884908003581
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K020936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2019
• Report Date (Section F): 08/09/2019

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
• Operator of Device: Other
• Device Expiration Date: 04/01/2020
• Device Model Number: ASPC24P-XL
• Device Catalogue Number: ASPC24P-XL
• Device Lot Number: MLCS960
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 YR
• Patient Weight: 14
• Date Report Sent to FDA: 08/09/2019