MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 12.5F X 90CM TRIP LMN CVC CATH; LT SILICONE CVC

Model Number	MR28011231
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received a triple lumen cvc silicone catheter from customer.Upon visual examination, the lumen had a cut/tear approximately 3 inches from the hub.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.A suture was tied around the catheter lumen approximately 3 inches from the hub.The cut in the lumen is just above the suture and is approximately 1/4" long and appears to be a clean cut, not rigged.There is no other visible damage or defects to the catheter.It is possible a sharp was used near the lumen to tie/cut the suture.The catheter showed no signs of degradation and the failure was not due to out of spec product.
Event or Problem Description
Surgeon reported "fracture on the catheter proximal to the exit site".

• Brand Name: 12.5F X 90CM TRIP LMN CVC CATH
• Common Device Name: LT SILICONE CVC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9221245
• Report Number: 2518902-2019-00066
• Device Sequence Number: 14136684
• Product Code: LJS
• UDI-Device Identifier: 00884908084320
• UDI-Public: 884908084320
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K003110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted 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): 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/21/2023
• Device Model Number: MR28011231
• Device Catalogue Number: MR28011231
• Device Lot Number: MNBV190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR