MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 9.5F X 90CM SGL LMN CVC CATH; LT SILICONE CVC

Model Number	MR28010911
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cvc was returned for evaluation.Visual inspection revealed a cut in the lumen approximately 1.4cm from the hub.The cut is a "v" shape indicating the lumen was exposed to a sharp object, such as the beveled end of a needle.It was determined that the lumen did not crack, but was pierced with a needle, causing the leak.Root cause of the issue is user error.
Event or Problem Description
Patient underwent epoprostenol infusion through the single lumen cvc catheter.Patient later summoned the nurse who found the patient had blood soaking through her gown.The nurse further investigated to find a crack in the cvc catheter near the site of insertion and suturing.Epoprostenol was transferred to an open peripheral line.Patient was taken for emergent replacement of the cvc catheter.

• Brand Name: 9.5F X 90CM SGL LMN CVC CATH
• Common Device Name: LT SILICONE CVC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9413111
• Report Number: 2518902-2019-00077
• Device Sequence Number: 14185402
• Product Code: LJS
• UDI-Device Identifier: 00884908084276
• UDI-Public: 884908084276
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

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: 05/14/2024
• Device Model Number: MR28010911
• Device Catalogue Number: MR28010911
• Device Lot Number: MNKN990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2019
• 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