MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 12.5FX28CM HEMO-CATH; HEMO-CATH LT

Model Number SL28E.

Device Problem Leak/Splash (1354)

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

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

No device was returned and no photographs were provided.Without an evaluation of the device involved we are unable to determine the cause or factors that may have contributed to this event.

Event Description

A leak was detected in the extension lines after the second dialysis session.

• Brand Name: 12.5FX28CM HEMO-CATH
• Type of Device: HEMO-CATH LT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 9529881
• MDR Text Key: 198552095
• Report Number: 2518902-2019-00081
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908045994
• UDI-Public: 884908045994
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K113487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2019
• Device Model Number: SL28E.
• Device Catalogue Number: SL28E.
• Device Lot Number: MNHY160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 24