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

Model Number ASPC24P-XL

Device Problem Break (1069)

Patient Problems Renal Failure (2041); Device Embedded In Tissue or Plaque (3165)

Event Date 08/02/2019

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated.Additional information and the sample have been requested.

Event 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.

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
• Type of Device: SPLIT CATH XL HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8909784
• MDR Text Key: 154867345
• Report Number: 2518902-2019-00055
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908003581
• UDI-Public: 884908003581
• Combination Product (y/n): N
• PMA/PMN Number: K020936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/09/2019,10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 08/09/2019
• Distributor Facility Aware Date: 08/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2019
• Date Manufacturer Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR
• Patient Weight: 14