MAUDE Adverse Event Report: MEDCOMP 8F X 12CM HEMO-CATH; HEMO-CATH ST HEMODIALYSIS CATHETER

Model Number SL12P

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 05/16/2017

Event Type  malfunction  

Manufacturer Narrative

Received a 8f st hemo-cath for evaluation.A visual inspection revealed a small hole slightly above the hub on the lumen.A functional analysis shows leaking from the hole.The device was forwarded to the device contract manufacturer for evaluation.

Event Description

Upon inspection after catheter removal a ~0.5cm crack on central part of tubing, before the hub that bifurcates on the posterior side, flush with pt.Skin was noted.

Manufacturer Narrative

Received a 8f st hemo-cath for evaluation.The device was forwarded to the device contract manufacturer for evaluation.An examination of the sample indicated there is a prominent crack on the lumen close to the hub.The crack is through the entire wall thickness, and was evident when failing the 45 psi air leak test.The investigation reviewed all manufacturing and inspection procedure and determined they were clear and adequate to produce a device that meets requirements and would have identified during the 100% leak testing during production.It was determined that the reported failure occurred after the product was released and is not associated with the manufacturing process.

• Brand Name: 8F X 12CM HEMO-CATH
• Type of Device: HEMO-CATH ST 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: 6657847
• MDR Text Key: 78259555
• Report Number: 2518902-2017-00028
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00884908045123
• UDI-Public: 884908045123
• 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: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2021
• Device Model Number: SL12P
• Device Catalogue Number: SL12P
• Device Lot Number: MCBL800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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