MAUDE Adverse Event Report: MEDCOMP 13.5F X 15CM SIL DBL LMN W/STYLE; HEMODIALYSIS CATHETER

Model Number SDL136E

Device Problems Air Leak (1008); Fluid/Blood Leak (1250)

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

Event Date 03/12/2013

Event Type  malfunction  

Event Description

The blood and air leak seems to be on the tubing at the level of the clamps.After observing the leak, a 2nd catheter from the same lot was inserted.The same leak occurred at the same location.

Manufacturer Narrative

Received two 13.5f x 15 cm silicone lumen catheters for evaluation.A visual inspection of the catheters reveals no physical damage.The first catheter tested did not leak when flushed.The second catheter was flushed and a leak was seen at the over-molded sleeve to extension junction.The extension with the leak was cross sectioned and measured.All measurements were within the design specifications.We are unable to determine the cause or factors which may have contributed to this event.

• Brand Name: 13.5F X 15CM SIL DBL LMN W/STYLE
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; harleysville PA
• Manufacturer (Section G): MEDCOMP; 1499 delp dr.; harleysville PA 19438
• Manufacturer Contact: susan smith, rn ; 1499 delp dr.; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 4554560
• MDR Text Key: 5522915
• Report Number: 2518902-2015-00019
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Model Number: SDL136E
• Device Catalogue Number: SDL136E
• Device Lot Number: MFQ410
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/08/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2011
• 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: 72 YR
• Patient Weight: 50