MAUDE Adverse Event Report: MEDCOMP 8F X 18CM HEMO-CATH; HEMO-CATH HEMODIALYSIS CATHETER

Model Number SL18P

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/13/2016

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated.When the investigation is complete a supplemental report will be submitted.

Event Description

During catheter exchange the catheter broke at the hub and had to be retrieved through the groin access.The catheter has been in place for approximately three months.During the retrieval procedure, the new catheter broke.All pieces were eventually removed from the patient.

Manufacturer Narrative

The device involved in the incident was not returned for evaluation.Attempts to obtain additional information and a 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: 8F X 18CM HEMO-CATH
• Type of Device: HEMO-CATH HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 6335732
• MDR Text Key: 67580383
• Report Number: 2518902-2017-00006
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908045444
• UDI-Public: 884908045444
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2017

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?: No
• Device Operator: Other
• Device Model Number: SL18P
• Device Catalogue Number: SL18P
• Device Lot Number: MCCB030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/16/2017
• Initial Date FDA Received: 02/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/01/2017
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR