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

Model Number	ML4S20
Medical Device Problem Code	Knotted (1340)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.The device will be decontaminated for safe handling and returned to the contract manufacturer for evaluation.
Event or Problem Description
Guidewire tip knotted in vein during insertion procedure-unable to remove.
Additional Manufacturer Narrative
Based on the investigation performed, it was determined that the product was manufactured to specifications at this time.The knot at the tip of the guidewire was confirmed, but we are unable to determine the cause or factors that contributed to this event.Previous investigations by the device manufacturer stated that possible contributing factors to the event may have been resistance in the guidewire during insertion and/or the patient's anatomy.The instructions for use state "do not advance the guidewire or catheter if unusual resistance is encountered".

• 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: 6958290
• Report Number: 2518902-2017-00057
• Device Sequence Number: 505514
• Product Code: LJS
• UDI-Device Identifier: 00884908030662
• UDI-Public: 884908030662
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2018

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/04/2020
• Device Model Number: ML4S20
• Device Catalogue Number: ML4S20
• Device Lot Number: MJFF500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 05/07/2018
• 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