MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 12.5FX18CM LT HEMO-CATH; HEMO-CATH LT HEMODIALYSIS CATHETER

Model Number	MC101242
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
Upon placing the patient back on a new crrt circuit, bedside staff noticed that the external portion of the catheter was oozing blood.A hole was identified.The hole was proximal to the patient, away from any connection points or clamps.Crrt treatment was stopped, line was clamped, and patient was taken to ir for line exchange.Two days later crrt alarmed for low access pressures.Bedside nurse removed patient from circuit to assess line.When she tried flushing the line, she noticed oozing coming from the external portion of the catheter.The hole was proximal to the patient, away from any connection points or clamps.She placed a tegaderm over the hole and clamped the line.Patient taken to ir for line exchange.Both devices are from the same lot.
Additional Manufacturer Narrative
No device was returned and no photographs provided.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test performed as a last step in the process.This test would have detected any holes, leaks, or weak spots in the device if it had existed at the time of manufacture.Without an evaluation of the complained devices a root cause cannot be determined.The instructions for use (ifu) contains the following precautions: do not use sharp instruments near the extension lines or tubing.Do not use scissors to remove dressing.Catheter will be damaged if clamps other than what is provided with this kit are used.Clamping the catheter repeatedly in the same location will weaken tubing.Avoid clamping near the luers and hub of the catheter.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 HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 12408416
• Report Number: 2518902-2021-00054
• Device Sequence Number: 14548295
• Product Code: MSD
• UDI-Device Identifier: 00884908082999
• UDI-Public: 884908082999
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 10/18/2021

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 Expiration Date: 07/30/2025
• Device Model Number: MC101242
• Device Catalogue Number: MC101242
• Device Lot Number: MPDL180 S2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 YR
• Patient Weight: 22