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

Model Number	ASPC28-3E.
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated.When the investigation is complete a final report will be submitted.
Event or Problem Description
When inserting the dilator with the check-valve during the catheter placement, the valve has not worked and a significant amount of blood flowed out.
Additional Manufacturer Narrative
No device or pictures were received for this complaint.The complaint information was sent to the device contract manufacturer for investigation.All processes and procedures were reviewed and were found to found be adequate.There were no non-conformities or deviations noted for this device during manufacturing.The root cause could not be accurately determined because the physical device was not returned for a complete analysis.We are unable to determine the cause or factors that may have contributed to this event.

• Brand Name: 14F X 28CM SPLIT CATH III
• Common Device Name: SPLIT CATH III HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6510814
• Report Number: 2518902-2017-00018
• Device Sequence Number: 18867637
• Product Code: MSD
• UDI-Device Identifier: 00884908003710
• UDI-Public: 884908003710
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2017

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: 08/27/2018
• Device Model Number: ASPC28-3E.
• Device Catalogue Number: ASPC28-3E.
• Device Lot Number: MHBH970
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: 03/23/2017
• Initial Report FDA Received Date: 04/21/2017
• Supplement Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 56