MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 15.5FX28CM PC TITAN CATHETER

Model Number	THD155228
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During dialysis a sucking air and bubbling noise was noted coming from the arterial line.The catheter was exchanged for another.Inspection of the explanted catheter revealed a defect at the hub connection.
Additional Manufacturer Narrative
We are currently waiting for 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.
Additional Manufacturer Narrative
The 15.5f titan catheter was returned for evaluation.Visual inspection confirms the complaint as a leak was noted at the lumen to hub junction.A functional test was conducted by injecting a blue liquid into the arterial extension, and leakage was observed at the lumen to hub junction, confirming the reported failure mode.A request was made for a cross-section of the hub to check the lumen insertion and measurement, but since the hub and the lumen have the same texture and color (white), no identifiable difference could be observed.Thus, it was not possible to measure.Device history records (dhr) were reviewed, and it was verified that the reported lot was manufactured within specifications.No amv?s (authorized manufacture variance) nor ncrs (non-conformance report) related to the reported failure mode (hub-lumen leakage).The manufacturing process includes a 100% leak test.The leak test is the final manufacturing operation before inspection and packaging.Its purpose is to identify potential damage, such as holes, ruptures, tears, and small pinholes that could cause leaks in the catheter.Based on the dhr review on the reported lot, it was found it was manufactured within specification according to applicable drawing and customer requirements.Due to failure mode couldn't be duplicated during engineering testing using the current molding validated parameters and due to this device was implanted on a patient during four months before the leak failure was detected, it is concluded that a root cause could not be attributable to the manufacturing process.We are unable to determine the cause or factors that may have contributed to this event.

• Brand Name: 15.5FX28CM PC TITAN CATHETER
• Common Device Name: TITAN 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: 16408026
• Report Number: 2518902-2023-00016
• Device Sequence Number: 12189615
• Product Code: MSD
• UDI-Device Identifier: 00884908053241
• UDI-Public: 00884908053241
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 05/30/2023

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 Expiration Date: 06/07/2024
• Device Model Number: THD155228
• Device Catalogue Number: THD155228
• Device Lot Number: MPZR840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 85 KG