MAUDE Adverse Event Report: MEDCOMP 7F X 90CM DBL LMN CVC CATH; LT SILICONE CVC

Model Number	MR28010721
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device sample was not returned for evaluation.Without an evaluation of the device involved we are unable to determine the cause or factors that may have contributed to this event.
Event or Problem Description
Blue lumen leakage from tear, just below the hub.Lumen was not used.

• Brand Name: 7F X 90CM DBL LMN CVC CATH
• Common Device Name: LT SILICONE CVC
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6834153
• Report Number: 2518902-2017-00046
• Device Sequence Number: 1430631
• Product Code: LJS
• UDI-Device Identifier: 00884908084283
• UDI-Public: 884908084283
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K003110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2021
• Device Model Number: MR28010721
• Device Catalogue Number: MR28010721
• Device Lot Number: MHMY460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 11