MAUDE Adverse Event Report: MEDCOMP 12.5FX28CM PC HEMO-CATH; HEMODIALYSIS CATHETER

Model Number SL28PC

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2014

Event Type  malfunction  

Event Description

Pin hole tear.

Manufacturer Narrative

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

Manufacturer Narrative

A visual inspection of the catheter revealed no outward physical damage.The catheter was flushed and pin hole leaks were discovered from both the arterial and venous extensions.The device was forwarded to the manufacturing facility for evaluation.Review of the device history records for this product showed it was manufactured according to all internal procedures.There was no failure with the over molding process or with the 100% leak testing done on this product.There have been no variances or non-conformances associated with this lot.Based on the investigation performed and the inspection of the sample provided it was concluded that the reported failure mode is not associated with the manufacturing process.We are unable to determine the cause or factors that may have contributed to this event.

• Brand Name: 12.5FX28CM PC HEMO-CATH
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: susan smith, rn ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 4611756
• MDR Text Key: 5660848
• Report Number: 2518902-2015-00032
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2015

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
• Device Operator: Other
• Device Model Number: SL28PC
• Device Catalogue Number: SL28PC
• Other Device ID Number: 884908046021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 03/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2015
• 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: 9 YR