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

Model Number	ASPC28-3E.
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: SPLIT CATH III
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8217626
• Report Number: 2518902-2019-00003
• Device Sequence Number: 19259972
• Product Code: MSD
• UDI-Device Identifier: 00884908003710
• UDI-Public: 884908003710
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K040318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 72