MAUDE Adverse Event Report: MEDCOMP 8F X 18CM HEMO-CATH; HEMODIALYSIS CATHETER

Model Number	SL18P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.The returned sample was forwarded to the contact manufacturer for evaluation.
Event or Problem Description
Catheter with a side hole, and while flushing, splash occurred due to hole or crack in the distance between extensions and cuff.
Additional Manufacturer Narrative
The investigation of the complaint included a review of the device history record, a review of the returned sample, and the manufacturing process.The device lots involved were manufactured and inspected to appropriate procedures.The catheters are 100% leak tested during the manufacturing process.As part of the investigation attempts were made to replicate the failure mode.The pin holes in the extension tubes could have been cause by engaging the clamp over the guidewire/stylet.The hole in the lumen at the hub could have been caused by a sharp object plus force applied to the main shaft.The failure modes are not considered to be associated with the manufacturing processes.

• Brand Name: 8F X 18CM HEMO-CATH
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7233589
• Report Number: 2518902-2018-00001
• Device Sequence Number: 2116846
• Product Code: MSD
• UDI-Device Identifier: 00884908045444
• UDI-Public: 884908045444
• Combination Product (Y/N): N
• Initial Reporter Country: BA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2018

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
• Operator of Device: Other
• Device Expiration Date: 11/30/2021
• Device Model Number: SL18P
• Device Catalogue Number: SL18P
• Device Lot Number: MCDS560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 02/01/2018
• Supplement Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 5