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

Model Number SL18P

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2022

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 305100578
• Report Number: 2518902-2022-00048
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908045444
• UDI-Public: 884908045444
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention