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

Model Number SL18P

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/11/2020

Event Type  malfunction  

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 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.

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
• Type of Device: HEMO-CATH LT HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10927007
• MDR Text Key: 221285142
• Report Number: 2518902-2020-00058
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908045444
• UDI-Public: 884908045444
• Combination Product (y/n): N
• PMA/PMN Number: K893439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention