MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 15.5FX28CM PC TTN HD CATH WOSH; TITAN HEMODIALYSIS CATHETER

Model Number	THD155628
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
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
When ending the treatment by reinfusion, the nurse suddenly heard a "pssst" sound.The nurse saw immediately that the catheter had come loose.The nurse closed the clamps and pushed the catheter back together out of intuitive reaction.This patient had minimal loss of blood because the nurse reacted in time.The patient also received a single dose of antibiotics.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation and no photographs were provided.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.The inspection process includes a pull test to ensure the luer connection to the extension tubing is secure.Without an evaluation of the device a root cause cannot be determined.The report indicated the catheter has been implanted for 6 years with no reported problems.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: 15.5FX28CM PC TTN HD CATH WOSH
• Common Device Name: TITAN 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: 12862834
• Report Number: 2518902-2021-00067
• Device Sequence Number: 17231218
• Product Code: MSD
• UDI-Device Identifier: 00884908053708
• UDI-Public: 884908053708
• Combination Product (Y/N): N
• Initial Reporter Country: NP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 12/17/2021

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: 11/30/2017
• Device Model Number: THD155628
• Device Catalogue Number: THD155628
• Device Lot Number: MBXX200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2015
• 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: Unknown