MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 11F X 20CM DL SIDE X SIDE IJ; SHORT TERM HEMODIALYSIS CATHETER

Model Number XTP118IJS=

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2024

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated.Currently waiting for additional information and 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.

Event Description

During the insertion procedure it was noted that the blue clamp did not work and the system sucked air in whilst the clamp was closed.

Manufacturer Narrative

The side-by-side ij catheter was returned for evaluation with a syringe attached to the arterial luer.Visual inspection revealed no obvious damage to the device.A functional test was performed by closing the device clamps and attempting to flush/aspirate through each of the luers.With the clamps closed it was not possible to flush or aspirate through either of the luers.The clamps sufficiently occluded the extension tube.The clamps were opened, and the lumen was clamped above the side holes.The device was flushed through both luers and no leaks were noted.No problem was found with the returned device.The reported failure could not be duplicated.The 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.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: 11F X 20CM DL SIDE X SIDE IJ
• Type of Device: SHORT TERM HEMODIALYSIS CATHETER
• 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: 18846975
• MDR Text Key: 337009507
• Report Number: 2518902-2024-00018
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

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
• Device Operator: Other
• Device Model Number: XTP118IJS=
• Device Catalogue Number: XTP118IJS=
• Device Lot Number: MPAG660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention