MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 12.5F X 90CM TRIP LMN CVC CATHETER; LT SILICONE CVC

Model Number	MR28011231
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
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
By salinizing the blue path of the hickman catheter, the white part of the extension to which the clave connector is connected became disconnected from the rest of the catheter.
Additional Manufacturer Narrative
No device was returned for evaluation.Photograph provided is not of the complained device.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.Excessive manipulation of the catheter luers during disinfection, connections (end caps, syringes, infusion lines) could potentially cause movement of the luers in the extension tubing.The report indicated the catheter has been implanted for over one month with no reported problems.The instructions for use include the following catheter precaution: examine catheter lumen and extensions before and after each treatment for damage.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: 12.5F X 90CM TRIP LMN CVC CATHETER
• Common Device Name: LT SILICONE CVC
• 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: 14622233
• Report Number: 2518902-2022-00038
• Device Sequence Number: 14794161
• Product Code: LJS
• UDI-Device Identifier: 00884908084320
• UDI-Public: 884908084320
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/29/2022

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 Expiration Date: 12/27/2025
• Device Model Number: MR28011231
• Device Catalogue Number: MR28011231
• Device Lot Number: MPKL560
• 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: 06/07/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2020
• 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