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

Model Number SL28PCE

Device Problems Hole In Material (1293); Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

Extension tubing leaking-hole.

Manufacturer Narrative

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

• 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: 4652192
• MDR Text Key: 20749494
• Report Number: 2518902-2015-00037
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: EC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SL28PCE
• Device Catalogue Number: SL28PCE
• Device Lot Number: UNKN0WN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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