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

Model Number	SL18P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
After 2 months usage, low clearance was detected (kt/v below 0.3), catheter was removed and checked with nss flush and found a leak across a and v lumens, cause of recirculation.Cross lumen leak.
Additional Manufacturer Narrative
We are 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.
Additional Manufacturer Narrative
The hemo-cath catheter was returned for evaluation.Functional inspection confirms the complaint as a cross-lumen leak was easily reproduced.The lumen was clamped off and water flushed through the device.When flushed through the arterial luer, water came out the venous luer.When flushed through the venous luer water came out the arterial luer.A supplier corrective action request was issued to the contract manufacturer.The contract manufacturer's investigation revealed a break in the wall between the two lumens.The root cause of the break is due to failure to properly follow the procedure during the molding process.As a result a new fixture was implemented to allow more space between the two sides, thus creating a more robust wall.The procedure was updated to include the new fixture and all personnel involved in the process were trained to the updated procedure.B3-date of event corrected 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 18CM HEMO-CATH
• Common Device Name: HEMO-CATH LT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 15182257
• Report Number: 2518902-2022-00048
• Device Sequence Number: 6355701
• Product Code: MSD
• UDI-Device Identifier: 00884908045444
• UDI-Public: 884908045444
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2022

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: 10/15/2023
• Device Model Number: SL18P
• Device Catalogue Number: SL18P
• Device Lot Number: MMBA690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2019
• 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 Sex: Unknown