MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 8F X 18CM HEMO-CATH; HEMO-CATH LT HEMODIALYSIS CATHETER

Model Number	SL18P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Currently 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
The mother saw the leak on the catheter because the dressing was wetted with blood.In the fluoroscopy a defect could be clearly proven.Thereupon the catheter was explanted.In the explanted catheter we could identify a defect in the arterial part.
Additional Manufacturer Narrative
The catheter was returned for evaluation.Visual inspection confirms the complaint as there is a small slit on the lumen just below the hub.Inspection under magnification shows the slit is smooth which is consistent with being cut by a sharp instrument such as scissors or a scalpel.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their review showed the device lot was manufactured according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test that would have detected this leak if it had occurred during the manufacture process.The device was implanted for a month prior to the incident.A definitive root cause cannot be determined but is most likely not manufacture related.The instructions for use (ifu) contains the following precautions: *do not use sharp instruments near the extension tubing or catheter lumen.*do not use scissors to remove dressing.Device was used for treatment, not diagnosis.

• Brand Name: 8F X 18CM 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: 10927007
• Report Number: 2518902-2020-00058
• Device Sequence Number: 11008547
• Product Code: MSD
• UDI-Device Identifier: 00884908045444
• UDI-Public: 884908045444
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K893439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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: 03/19/2023
• Device Model Number: SL18P
• Device Catalogue Number: SL18P
• Device Lot Number: MMAN120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 12/11/2020
• 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