MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 11.5FX 4-3/4 DUO-FLOW IJ CATHETER

Model Number	XTP114IJSE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation and is entering the investigation process.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
Hemodialysis was initiated for patient.After 10 minutes found dressing soaked with blood.Blood leaked out between the split connector and blue extension line.Hemodialysis unable to proceed.New catheter was inserted with different batch.
Additional Manufacturer Narrative
The duo-flow catheter was returned for evaluation.Visual inspection confirms the complaint as flushing the device through the venous luer results in leakage at the hub.Under magnification it was noted that the extension tubing is torn at the edge of the hub.The portion of the tear most exterior to the hole appears smooth, as if cut with a sharp instrument.As the hole continues through the tubing it becomes more jagged.This condition suggests the tubing was nicked/cut creating a weak spot and over time, the tubing continued to tear.A supplier corrective action request was issued to the contract manufacturer for this event.Their investigation confirmed the above noted condition of the tubing.A review of the manufacture records for the lot number reported revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test performed as a last step in the process.This test would have detected any leaks, holes, or weak spots if it had existed at the time of manufacture.A definitive root cause cannot be determined but is not likely manufacture related.The instructions for use (ifu) contains the following warnings and precautions: *do not use sharp instruments near the extension tubing or catheter lumen.*do not use scissors to remove dressing.*catheter will be damaged if clamps other than what is provided with this kit are used.*clamping of the tubing repeatedly in the same location may weaken tubing.Avoid clamping near the luers and hub of the catheter.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.

• Brand Name: 11.5FX 4-3/4 DUO-FLOW IJ CATHETER
• Common Device Name: DUO-FLOW IJ
• 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: 15742779
• Report Number: 2518902-2022-00067
• Device Sequence Number: 20249070
• Product Code: MPB
• UDI-Device Identifier: 00884908058857
• UDI-Public: 00884908058857
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 01/12/2023

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 Model Number: XTP114IJSE
• Device Catalogue Number: XTP114IJSE
• Device Lot Number: MMHM110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2021
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 44 KG