MAUDE Adverse Event Report: MEDCOMP 14F X 28CM SPLIT CATH III

Model Number ASPC28-3E.

Device Problem Leak/Splash (1354)

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

Event Date 12/04/2018

Event Type  malfunction  

Event Description

When connecting the patient, air was inside the 2 catheter branches.The dialysis session was immediately stopped and the doctors were called.Blood presence was on the dressing.With a visual inspection, it was noticed a cut between the triangle and the catheter part on the patient side.The catheter was removed by the doctor.No clinical consequences for the patient.

Manufacturer Narrative

Based on the investigation performed, the product was manufactured according to required specifications.100% visual and functional (leak test) inspections are performed during the manufacture of the material as detection control; and the fact that product was implanted for 2 years 8 months with no reported problems, it is concluded that a root cause could not be attributable to the manufacturing processes.

• Brand Name: 14F X 28CM SPLIT CATH III
• Type of Device: SPLIT CATH III
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8217626
• MDR Text Key: 132783266
• Report Number: 2518902-2019-00003
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908003710
• UDI-Public: 884908003710
• Combination Product (y/n): N
• PMA/PMN Number: K040318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

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
• Device Operator: Other
• Device Expiration Date: 10/05/2018
• Device Model Number: ASPC28-3E.
• Device Catalogue Number: ASPC28-3E.
• Device Lot Number: MHDB400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 12/04/2018
• Supplement Dates FDA Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 72