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

Model Number	MLCT4S20
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation is ongoing.A follow up report will be submitted when the investigation is complete.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.
Event or Problem Description
During midline insertion on right brachial vein, guidewire well positioned with ultrasound, after peel-away insertion, guidewire removal was limited by obstacles.All peel-away plus guidewire was removed and the tip of guidewire was coiled.After small bleeding stop, new set was used and placed correctly.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation and no photographs were provided.A record review request was sent to the device contract manufacturer.The inspection method performed was a device history record (dhr) review.The review revealed the following: - no internal nonconformance reports were found on the batch reported.- personnel was properly trained.- the reviews of the dhr demonstrate compliance and conformance to applicable procedures and specifications.- pull test results were verified and it was confirmed the batch meet the tensile specifications.- there is no evidence to confirm that this event is caused by manufacturing deviations.- therefore, it is considered a non-manufacturer-related issue.- the root cause is indeterminable.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.

• 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: 13792174
• Report Number: 2518902-2022-00021
• Device Sequence Number: 3906776
• Product Code: PND
• UDI-Device Identifier: 00884908113730
• UDI-Public: 884908113730
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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: 09/24/2024
• Device Model Number: MLCT4S20
• Device Catalogue Number: MLCT4S20
• Device Lot Number: MPXA660 S2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2021
• 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 Age: 86 YR
• Patient Sex: Unknown