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

Model Number	DMC101243
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient received new hd catheter (b)(6) 2026, the line was accessed and used for hemodialysis both (b)(6) 2026 and (b)(6) 2026 without issue.When line accessed (b)(6) 2026, noted pin prick spray/leak from both red and blue lumens.Nephrologist notified, labs collected.After reviewing labs nephrologist determined labs are stable and dialysis was not urgent.Ir team contacted direct by nephrologist for new line placement.
Additional 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.
Additional Manufacturer Narrative
The 12.5f hemo-cath was returned for evaluation.Visual inspection of the returned device revealed approximately 3 cm of the proximal lumen contains cross stitch sutures.Both extensions also contain subclavian clips.Functional testing was performed by clamping the distal end of the lumen.When flushed through each of the luers a small leak was noted in the extension tubing just below the luer sleeves.When each extension was viewed under magnification it was noted that the leaks are coming from two holes, each almost directly across from the other.This suggests the holes were created by pinching the extension tubing, possibly with the clamp or hemostats.The contract manufacturer conducted a review of the manufacturing records for the lot number reported.The 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 for 5 days with no reported issues.This leads to the conclusion that the failure was not likely a manufacturing issue.It is possible the device was damaged during use or maintenance such as during a dressing change.The instructions for use (ifu) contains the following warnings: *do not use sharp instruments near the extension tubing or catheter lumen.*do not use scissors to remove dressing.*do not clamp the dual lumen portion of the catheter.Clamp only the extensions.Do not use serrated forceps, use only the in-line clamps provided.*catheter will be damaged if clamps other than what is provided with this kit are used.*clamping of the tubing repeatedly in the same location may weaken tubing.Avoid clamping near the luers and hub of the catheter.*do not clamp over guidewire or stylet - tubing may become damaged.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®
• Common Device Name: LT HEMO-CATH
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 24145159
• Report Number: 2518902-2026-00006
• Device Sequence Number: 21203955
• Product Code: MSD
• UDI-Device Identifier: 00884908140835
• UDI-Public: (01)00884908140835(17)300722(10)MRXP380
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K113487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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?: No
• Operator of Device: Other
• Device Model Number: DMC101243
• Device Catalogue Number: DMC101243
• Device Lot Number: MRXP380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2025
• 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: 13 YR
• Patient Sex: Male
• Patient Weight: 39 KG