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	08/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The distributor informed us that according to regional law, the hospital will have to keep the device involved for 6 months starting from the date of the incident.The device will not be returned for analysis until february 2018.
Event or Problem Description
During midline insertion needle was inserted with good venous reflux.When the wire was introduced it was possible to advance only a few centimeters until it stopped.During withdrawal of the guidewire resistance was noted.A knot was noted with ultrasound.Surgery was required to remove the wire.
Additional Manufacturer Narrative
No device or pictures were received for evaluation.A record review was completed by the device manufacturer based on the lot number and no deviations or non-conformities were found.The device was made to specification.Without sufficient information, or an evaluation of the device involved, we are unable to determine the root cause for 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/removal and/or the patient's anatomy.The incident report said that the guidewire was unable to advance and during withdrawal resistance was felt.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: 6861483
• Report Number: 2518902-2017-00049
• Device Sequence Number: 873075
• Product Code: LJS
• UDI-Device Identifier: 00884908030662
• UDI-Public: 884908030662
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: 121094
• 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): 05/24/2018

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: 03/18/2020
• Device Model Number: ML4S20
• Device Catalogue Number: ML4S20
• Device Lot Number: MJCH310
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 05/25/2018
• 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: 87 YR