MAUDE Adverse Event Report: MEDCOMP 16F X 28CM SPLIT CATH III

Model Number	RMS23602
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816)
Date of Event	06/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We are unable to determine the cause or factors that may have contributed to this event.Simulated clamping tests to validate that the clamp will function as intended on the catheter extension is performed.The clamps are run through over 1,000 cycles and visually examined for excessive wear (physical deterioration, and cracks).
Event or Problem Description
Dialysis initiated using the patient's avf.The venous needle infiltrated and the dialysis treatment was converted to using the patient's right internal jugular catheter, it was noted the arterial red clamp was cracked and unable to be clamped.Dialysis treatment was terminated, catheter ports flushed and capped.Upon patient ambulating to scale patient began coughing, complained of shortness of breath and severe chest pain.911 was called.Patient was transported to the hospital and admitted.Patient was discharged from the hospital 3 days later.

• Brand Name: 16F X 28CM SPLIT CATH III
• Common Device Name: SPLIT CATH III
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8750272
• Report Number: 2518902-2019-00039
• Device Sequence Number: 16654731
• Product Code: MSD
• UDI-Device Identifier: 00884908038583
• UDI-Public: 884908038583
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K040318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2019
• Report Date (Section F): 06/13/2019

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: Health Professional
• Device Expiration Date: 04/01/2020
• Device Model Number: RMS23602
• Device Catalogue Number: RMS23602
• Device Lot Number: MLDQ960
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/01/2019
• 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: Life Threatening; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 125