MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 14FX20CM DUO-FLOW 400XL

Model Number	DFXL148MTE
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
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
The entire catheter comes out of the patient, leaving the blue wing, that comes with the device from the factory, attached to the skin by the stitches.Catheter came out by itself.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation and no photographs were provided.The device contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.A process review indicated that when attaching the suture wing to the hub, the operator must push firmly until the suture wing has entered the slot and is secured after the suture wing is assembled onto the hub, it is rotated several times to ensure free movement and proper positioning on the hub.A review of the engineering verification testing noted that all samples tested exceeded the suture wing iso pull force requirements.Without an evaluation of the device involved in the incident we are unable to determine the cause or factors that may have contributed to this event; however, it appears that enough force was applied to the catheter to dislodge it from the suture wing.

• Brand Name: 14FX20CM DUO-FLOW 400XL
• Common Device Name: DUO-FLOW 400XL
• 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: 13660075
• Report Number: 2518902-2022-00020
• Device Sequence Number: 12023496
• Product Code: MPB
• UDI-Device Identifier: 00884908009200
• UDI-Public: 884908009200
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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 Model Number: DFXL148MTE
• Device Catalogue Number: DFXL148MTE
• Device Lot Number: MPZM910 S2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/03/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 95 KG