MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 8F X 18CM HEMO-CATH; HEMO-CATH LT

Model Number SL18P

Device Problem Leak/Splash (1354)

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

Event Date 08/18/2023

Event Type  malfunction  

Manufacturer Narrative

We are currently waiting for the device to be returned for evaluation.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 Description

Since (b)(6) 2023, at every dialysis connection, the patient's catheter, implanted on (b)(6) 2022, showed micro-leaks of blood, soaking the central line dressing and running down the dialysis lines.After several days of searching for the cause of this leakage, we discovered a kink and crack in the catheter between the cuff and the y-connector.The doctors were immediately notified and the catheter was removed in the afternoon so that a new one could be implanted.

Manufacturer Narrative

One intact 8f x 18cm long-term hemo-cath was received for evaluation.A visual examination was performed.There were no obvious defects.A functional evaluation indicated kink and a tiny hole in the arterial lumen ~1.5cm distal to the hub.The hole was difficult to detect and visualize even under the microscope.We are unable to determine the cause or factors that may have contributed to this event.The catheter was implanted for over 1 year prior to the incident.Therefore, the cause of the failure is unlikely to be manufacturing related.The length of implantation may have been a contributing factor as there would be a direct correlation between the length of time a catheter is implanted and the exposure of the device to many variables for which the manufacturer has no influence or control.These variables include but are not limited to patient physiology, care and maintenance of the catheter by healthcare providers and the patient, exposure to site care agents and ointments, locking solutions, and off label uses such as medication administration.

• Brand Name: 8F X 18CM HEMO-CATH
• Type of Device: HEMO-CATH LT
• 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: 18011770
• MDR Text Key: 326619509
• Report Number: 2518902-2023-00070
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: SL18P
• Device Catalogue Number: SL18P
• Device Lot Number: MPLJ420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2021
• 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
• Patient Age: 3 YR
• Patient Sex: Male
• Patient Weight: 16 KG