MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 3F MST W/40CM WIRE & 22GA S-N; MICROSTICK TEARAWAY INTRODUCER

Model Number	DMR1903424S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
Type of Reportable Event	Serious Injury
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
2.6 fr medcomp picc attempted using the 3 fr mst kit.Left cephalic meeting catheter to vein ratio was accessed with 1 attempt using ultrasound.No difficulty placing the guidewire and peel away introducer.Picc would not thread past 4 cm and picc insertion aborted.Following picc line attempt, a small wire was captured on xray in the left arm of the patient just proximal to the insertion site where the picc line was attempted.The wire was not noted on radiology reads in their dictation.On (b)(6) 2026 the parent noted a dark spot on the patient and felt an object slightly protruding from below the skin which she pulled on and subsequently removed a 2 cm wire.She reported the wire was protruding from a site lateral to the biceps, a few centimeters away from small, needle-point sized scar over the inner left upper arm.

• Brand Name: 3F MST W/40CM WIRE & 22GA S-N
• Common Device Name: MICROSTICK TEARAWAY INTRODUCER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 25778768
• Report Number: 2518902-2026-00046
• Device Sequence Number: 9607975
• Product Code: DYB
• UDI-Device Identifier: 00884908144598
• UDI-Public: (01)00884908144598(17)270731(10)MRWR710
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K130687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2026

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 Model Number: DMR1903424S
• Device Catalogue Number: DMR1903424S
• Device Lot Number: MRWR710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 07/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2025
• 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: Female
• Patient Weight: 8 LB