MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. HEMO-CATH® ST SILICONE DOUBLE LUMEN CATHETER; HEMO-CATH ST

Model Number	DSL20
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.Currently waiting for additional information and 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.
Event or Problem Description
Catheter placed without issue.The patient returned to the floor and was immediately hooked up to crrt.The line worked for less than a minute before blood started leaking from the clear portion of the catheter.The patient had to return to ir for catheter replacement under sedation.
Additional Manufacturer Narrative
The 11.5f silicone hemo-cath catheter was returned for evaluation.Functional testing was performed by clamping the distal lumen with hemostats then flushing the catheter.When flushed through the arterial luer there were no leaks noted.When flushed through the venous luer a leak was noted from the extension tubing approximately 1.5 cm from the distal end of the luer.The leak was noted to be coming from two holes directly opposite each other on the tubing.Under magnification the holes appear to be "pinched".The device was further reviewed by medcomp engineering.The clamp was evaluated, no flash or sharp edges were noted.The condition of the device and the location of the holes are indicative of either clamping over the stylet or clamping "off-center", causing a pinch in the tubing.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 manufacture process includes a 100% leak test.This test would have detected any gaps such as holes, tears, or non-bonded unions that could lead to an assembly detachment, malfunction, or leaks.A definitive root cause cannot be determined but is not likely manufacture related.A warning label stating "do not clamp over guidewire/stylet" is affixed to the catherer.In addition, the instructions for use contains the following warnings and precautions: *do not clamp over guidewire or stylet - tubing may become damaged.*do not use sharp instruments near the extension lines or tubing.Do not use scissors to remove dressing, as this could possibly cut or damage catheter.Do not suture through any part of the catheter.Catheter tubing can tear when subjected to excessive force or rough edges.*use only smooth jawed forceps for clamping when not using the clamp supplied with the catheter.We recommend using only line extension clamps which have been provided for clamping.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: HEMO-CATH® ST SILICONE DOUBLE LUMEN CATHETER
• Common Device Name: HEMO-CATH ST
• 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: 20817972
• Report Number: 2518902-2024-00080
• Device Sequence Number: 7683761
• Product Code: MPB
• UDI-Device Identifier: 00884908141825
• UDI-Public: 00884908141825
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K890029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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?: No
• Operator of Device: Other
• Device Expiration Date: 09/17/2025
• Device Model Number: DSL20
• Device Catalogue Number: DSL20
• Device Lot Number: MQRR970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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: 20 YR
• Patient Sex: Male
• Patient Weight: 61 KG