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

Model Number	DSL18P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 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
Catheter was leaking around the site and not functioning properly.
Additional Manufacturer Narrative
The 8f silicone hemo-cath was returned for evaluation.Adhesive and multiple sutures were removed from the proximal end of the lumen.Functional testing was performed on the returned device.The distal end of the lumen was clamped with hemostats.When flushed through the venous luer no leaks were noted.When flushed through the arterial luer, a leak was noted approximately 0.5 cm proximal to the cuff.Under magnification the hole in the lumen appears smooth in the center but jagged at the edges.This is indicative of being cut and then torn.The device was evaluated by medcomp engineering.The condition of the returned device suggests the sutures that were tightly wrapped around the lumen cut into the silicone tubing and, over time, may have resulted in the tear.The instructions for use (ifu) states, "suture the catheter to the skin using the suture wing.Do not suture the catheter 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 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.A definitive root cause cannot be determined but is not likely manufacturing related.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® LT SILICONE DOUBLE LUMEN CATHETER
• Common Device Name: 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: 20374871
• Report Number: 2518902-2024-00058
• Device Sequence Number: 17859623
• Product Code: MSD
• UDI-Device Identifier: 00884908144895
• UDI-Public: 00884908144895
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K893439
• 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): 10/09/2024

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 Model Number: DSL18P
• Device Catalogue Number: DSL18P
• Device Lot Number: MQYH350
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/04/2024
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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: 5 YR
• Patient Sex: Male
• Patient Weight: 15 KG