MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 15.5F X 28CM PC HEMO-FLOW XF

Model Number	MC641522
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple attempts for clarification of event, and additional information were unsuccessful.Without knowing what component of the device failed, and how it failed, no further investigation is possible.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Information received from maude report mw5096104: patient was receiving dialysis at bedside.Dialysis nurse noticed bleeding from the blue port.When seen the plastic part near the blue port was open.Catheter was then removed.The tip of the catheter was sent for culture.Dressing applied to right chest, no further bleeding.

• Brand Name: 15.5F X 28CM PC HEMO-FLOW XF
• Common Device Name: HEMO-FLOW XF
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10573072
• Report Number: 2518902-2020-00043
• Device Sequence Number: 11548024
• Product Code: MSD
• UDI-Device Identifier: 00884908084016
• UDI-Public: 884908084016
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K994105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2020

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: Health Professional
• Device Expiration Date: 08/10/2022
• Device Model Number: MC641522
• Device Catalogue Number: MC641522
• Device Lot Number: MNWA610
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 09/23/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention