MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 12.5FX18CM LT HEMO-CATH; HEMO-CATH® LT SILICONE DOUBLE LUMEN CATHETER

Model Number	DMC101242
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When performing routine flushing hemodialysis catheter, 2 pinholes noted to external portion of blue limb of catheter lumen.Md notified immediately and central venous line was locked with normal saline.Urgent vascath replacement performed.The following day dayshift bedside rn noticed small amount of blood on outside circumference of blue lumen of newly ir placed tunneled dialysis catheter.Upon further inspection, a small pinhole was noted on the external portion of the blue lumen.Md immediately notifiec as well as ir and peds nephrologist.
Additional Manufacturer Narrative
Currently waiting for additional information.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.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation and no photographs were provided.Attempts to obtain additional information were unsuccessful.The contract manufacturer conducted a review of the manufacturing records for the catheter lot number reported.The device history record (dhr) review showed the lot was manufactured according to specifications.Without an evaluation of the device involved we are unable to determine the cause or factors that may have contributed to this event.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: 12.5FX18CM LT HEMO-CATH
• Common Device Name: HEMO-CATH® LT SILICONE DOUBLE LUMEN CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: susan smith ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 23975778
• Report Number: 2518902-2026-00003
• Device Sequence Number: 18817423
• Product Code: MSD
• UDI-Device Identifier: 00884908140828
• UDI-Public: (01)00884908140828(17)300905(10)MRYM170
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K113487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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 Model Number: DMC101242
• Device Catalogue Number: DMC101242
• Device Lot Number: MRYM170
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2025
• 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: 12 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American