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 10/24/2023

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

The nurse has detected a leak at the arterial lumen outside the body.This leak is just above the catheter wing on the aterial lumen, outside the patient's body.The catheter had to be changed under anesthesia.There were no complications for the patient.

Manufacturer Narrative

The hemo-cath was returned for evaluation with only 0.8cm of the lumen attached and hemostats clamped on the distal end of the lumen.The internal portion of the lumen was not returned.The arterial extension has an unknown white clamp on the distal portion of the extension tubing.Visual inspection revealed a hole in the arterial lumen approximately 0.1cc from the hub that leaks when the device is flushed.Under magnification the edges of the hole are smooth.It appears that the hole is an external cut in the lumen possibly made by a sharp instrument such as scissors or a scalpel.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 manufacturing process includes a 100% leak test performed as a last step in the process.This test would have detected any leaks, holes, or weak spots if it had existed at the time of manufacture.The device was implanted and functioned with no issues for more than 5 months prior to this event.A definitive root cause cannot be determined but is not likely manufacture related.The instructions for use (ifu) contains the following warnings and precautions: *do not use sharp instruments near the extension tubing or catheter lumen.*do not use scissors to remove dressing.*the catheter will be damaged if clamps other than what is provided with this kit are used.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: 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: 18010776
• MDR Text Key: 326606964
• Report Number: 2518902-2023-00069
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 11/06/2023

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: MPQV700
• 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: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2021
• 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: 5 YR