MAUDE Adverse Event Report: MEDCOMP 4F X 20CM SINGLE LUMEN MIDLINE

Model Number	ML4S20
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	05/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated.We are currently waiting to confirm the device sample will be returned for evaluation.When the investigation is complete a final report will be submitted.
Event or Problem Description
During catheter placement, metal guidewire knotted making removal difficult.
Additional Manufacturer Narrative
Received a 0.018' guidewire for evaluation.A visual inspection revealed the guidewire to be in a knot at the tip.The guidewire was forwarded to the device manufacturer for further evaluation.Based on the investigation, the root cause was on determined to be a manufacturing issue.Contributing factors could have been wire manipulation during the insertion procedure.The instructions for use state; do not advance the guidewire or catheter if unusual resistance is encountered.Do not insert or withdraw the guidewire forcibly from any component.

• Brand Name: 4F X 20CM SINGLE LUMEN MIDLINE
• Common Device Name: MIDLINE
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6657234
• Report Number: 2518902-2017-00029
• Device Sequence Number: 19172566
• Product Code: LJS
• UDI-Device Identifier: 00884908030662
• UDI-Public: 884908030662
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2018

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?: No
• Operator of Device: Other
• Device Expiration Date: 09/03/2019
• Device Model Number: ML4S20
• Device Catalogue Number: ML4S20
• Device Lot Number: MHTV620
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/25/2017
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 03/02/2018
• 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
• Patient Age: 68 YR