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

Model Number MCDLTSL18P

Device Problem Insufficient Information (3190)

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

Event Date 03/22/2019

Event Type  malfunction  

Event Description

During aspiration large amounts of air was reported in the lumens.Lumens were clamped, catheter was later replaced.

Manufacturer Narrative

Attempts to obtain additional information and the sample for evaluation were unsuccessful.No further investigation is possible at this time.Without an evaluation of the device involved we are unable to determine the cause or factors that may have contributed to this event.

• Brand Name: 8F X 18CM HEMO-CATH LT
• Type of Device: HEMO-CATH LT HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8537197
• MDR Text Key: 142674079
• Report Number: 2518902-2019-00025
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908026115
• UDI-Public: 884908026115
• Combination Product (y/n): N
• PMA/PMN Number: K893439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2018
• Device Model Number: MCDLTSL18P
• Device Catalogue Number: MCDLTSL18P
• Device Lot Number: MCAG040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention