MAUDE Adverse Event Report: MEDCOMP 14F X 32CM SPLIT CATH III

Model Number	ASPC32-3E.
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.
Event or Problem Description
A new catheter dressing was applied and the catheter was tested.Air bubbles were present when suctioning the venous branch.A crack was noted just below the suture wings.Patient was hospitalized, the split cath was removed and a femoral catheter was inserted.Patient is chronically dialyzed.
Additional Manufacturer Narrative
Based on the investigation performed, where it was found the device was manufactured according to specification, and the fact that the device was in use for 2 years and 7 months with no issue, it was determined that the event was not caused by a manufacturing issue.The root cause of this issue cannot be determined.

• Brand Name: 14F X 32CM SPLIT CATH III
• Common Device Name: SPLIT CATH III
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8591340
• Report Number: 2518902-2019-00030
• Device Sequence Number: 13956039
• Product Code: MSD
• UDI-Device Identifier: 00884908003895
• UDI-Public: 884908003895
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

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: 09/25/2018
• Device Model Number: ASPC32-3E.
• Device Catalogue Number: ASPC32-3E.
• Device Lot Number: MHCT000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 07/25/2019
• 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: 69 YR
• Patient Weight: 90