MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 4F SINGLE CT MIDLINE

Model Number	MLCT4S20
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Ultrasound guided vein identification before positioning the catheter.The needle was inserted into the vein.When venous blood flowed back, the guidewire was introduced and proceeded into the vein a few centimeters but then it stopped.The needle was removed, while the guide was stuck under the skin and does not come out.Traction was performed until it came out.Compressive bandage was applied.The guidewire was knotted.
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
The guidewire was returned for evaluation.Visual inspection confirms the complaint as the wire is knotted approximately 1.5 cm from the distal tip.There was a great deal of tissue ensnared within the knot.The guidewire was forwarded to the device contract manufacturer for further evaluation.The contract manufacturer's investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.Inspection of the returned device revealed all measurements of the device were within specification.A root cause cannot be determined but is not likely manufacture related.A possible cause of the knotted tip could be a back-and-forth motion during insertion.This can cause the wire to fold back on itself and result in a knotted tip.This may also cause the wire to be difficult to remove, resulting in applying more forces than the device is designed to withstand in order to remove it.The instructions for use (ifu) contains the following warnings: do not advance the guidewire or catheter if unusual resistance is encountered.Do not insert or withdraw the guidewire forcibly from any component.The wire may break or unravel.If the guidewire becomes damaged, the introducer needle or sheath/dilator and guidewire must be removed together.Device was used for treatment, not diagnosis.

• Brand Name: 4F SINGLE CT MIDLINE
• Common Device Name: CT MIDLINE
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 16463241
• Report Number: 2518902-2023-00018
• Device Sequence Number: 2381194
• Product Code: PND
• UDI-Device Identifier: 00884908113730
• UDI-Public: 00884908113730
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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: 12/29/2025
• Device Model Number: MLCT4S20
• Device Catalogue Number: MLCT4S20
• Device Lot Number: MQNX690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown