MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 7F X 90CM DBL LMN CVC CATH; LT SILICONE CVC

Model Number	MR28010721
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information and the device sample have been requested.
Event or Problem Description
Facility reported the double lumen catheter broke.
Additional Manufacturer Narrative
A visual examination of the device revealed a tear of the lumen near the hub of the catheter.The returned device was forwarded to medcomp engineering for further evaluation.The sample was examined under a microscope and measurements of the lumen profile were taken.The lumen diameters and wall thickness were found to be within specification.Visual inspection of the catheter during placement would have identified any external damage to the catheter caused during manufacturing or transit.The cut in the lumen is abnormal.The use of hemostats may have contributed to the failure mode.Based on the information provided by the facility and the investigation, the root cause of this issue cannot be determined.

• Brand Name: 7F X 90CM DBL LMN CVC CATH
• Common Device Name: LT SILICONE CVC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9105998
• Report Number: 2518902-2019-00062
• Device Sequence Number: 2448083
• Product Code: LJS
• UDI-Device Identifier: 00884908084283
• UDI-Public: 884908084283
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K003110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2019

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 Model Number: MR28010721
• Device Catalogue Number: MR28010721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 11/08/2019
• 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