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

Model Number	SL18P
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned for evaluation.A record and dhr review cannot be conducted as no lot number was provided.Without a physical evaluation of the device, a definitive root cause cannot be determined.
Event or Problem Description
The red and blue luers on the end of the extension lines were noted to be loose at the point of disconnection from the dialysis treatment.The nurses were able to rotate the hub in the sleeve and it was visibly loose.Alcohol prep pads are used to cleanse the lines, using a total of about 8-10 prep pads during the connection and disconnection process.More pads are used if the patient's line has to be reversed at any point during treatment.

• Brand Name: 8F X 18CM HEMO-CATH
• Common Device Name: HEMO-CATH LT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8785000
• Report Number: 2518902-2019-00041
• Device Sequence Number: 2338596
• Product Code: MSD
• UDI-Device Identifier: 00884908045444
• UDI-Public: 884908045444
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K893439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: SL18P
• Device Catalogue Number: SL18P
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR