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

Model Number	SL12P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: HEMO-CATH ST HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6657847
• Report Number: 2518902-2017-00028
• Device Sequence Number: 18864976
• Product Code: MDS
• UDI-Device Identifier: 00884908045123
• UDI-Public: 884908045123
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1