MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 8F X 12CM HEMO-CATH; HEMO-CATH ST HEMODIALYSIS CATHETER

Model Number	SL12P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.Currently we are waiting for 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
Leakage from the extension tube was discovered while flushing the catheter prior to hemodialys.
Additional Manufacturer Narrative
The 8f hemocath was returned for evaluation.Visual inspection revealed the arterial extension was clamped right at the luer sleeve.The arterial extension was pinched at the location of the clamp and could not be opened.Testing of the venous side revealed a leak in the extension line approx.03 cm from the luer sleeve.Under magnification the hole appears to be a stick by a sharp object.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 as a last step in the process.This test would have detected any holes, leaks, or weak spots in the device if they had existed at the time of manufacture.A definitive root cause cannot be determined but is not likely manufacture related.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: 8F X 12CM HEMO-CATH
• Common Device Name: HEMO-CATH ST HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 12358886
• Report Number: 2518902-2021-00051
• Device Sequence Number: 19791792
• Product Code: MPB
• UDI-Device Identifier: 00884908045123
• UDI-Public: 884908045123
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 07/31/2024
• Device Model Number: SL12P
• Device Catalogue Number: SL12P
• Device Lot Number: MPHA200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 08/24/2021
• 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