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

Model Number SL18P

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 03/25/2022

Event Type  malfunction  

Manufacturer Narrative

Our investigation is ongoing.A follow up report will be submitted when the investigation is complete.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

At the end of dialysis session, a nurse found the catheter with a little crack near to the clamp on the venous branch.Repair of the catheter using a kit sent by the distributor.The repair kit is not approved for use on this device and there is a concern that the device may require replacement.Dialysis continues with the repaired device.

Manufacturer Narrative

No device was returned.No lot number was reported.Attempts to obtain this information were unsuccessful.Without the lot number a review of the manufacture records is not possible.It was reported the medcomp repair kit rpk-01 was used to repair the extension.This repair kit is not approved for use on this device and is considered off-label use.Without an evaluation of the device a root cause cannot be determined.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

No device was returned.Multiple requests for the lot number were not successful.Without a lot number and no device not investigation is possible.Complaint was closed.Lot number was later provided.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test performed as a last step in the process.This test would have detected any leaks, holes, or weak spots if it had existed at the time of manufacture.Without an evaluation of the device a root cause cannot be determined.The instructions for use (ifu) contains the following precautions: do not use iodine or iodine based disinfectants on this catheter.Failure of catheter will occur.Alcohol based solutions are recommended as the antiseptic solution that can be used on this catheter.Do not use sharp instruments near the extension tubing or catheter lumen.Do not use scissors to remove dressing.Catheter will be damaged if clamps other than what is provided with this kit are used.Clamping of the tubing repeatedly in the same location may weaken tubing.Avoid clamping near the luers and hub of the catheter.It was reported the medcomp repair kit rpk-01 was used to repair the extension.This repair kit is not approved for use on this device and is considered off-label use.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 HEMODIALYSIS CATHETER
• 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: 14101493
• MDR Text Key: 289491583
• Report Number: 2518902-2022-00027
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908045444
• UDI-Public: 884908045444
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• 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: MMAF230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2018
• 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
• Patient Age: 3 YR