MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 11.5FX20CM HEMO-CATH ST

Model Number SL20E.

Device Problem Leak/Splash (1354)

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

Event Date 06/24/2023

Event Type  malfunction  

Event Description

Leak on the venous branch of the jugular catheter.Blood was observed at the bandage.

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 silicone hemo-cath was returned for evaluation.Visual inspection confirms the complaint as flushing through the venous luer results in a small pin-hole leak in the extension tubing just below the luer sleeve.A supplier investigation request was issued to the contract manufacturer.The contract manufacturer conducted a review of the manufacture records for the lot number reported.The review revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.The manufacturing 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 existing at the time of manufacture.An evaluation of the returned device was conducted by the contract manufacturer.The sample was tested by injecting water through the vein side and clamping the mainshaft.After a few seconds the water leaked through the extension very close to the overmolded section.A visual inspection using magnification was performed and two small holes can be seen in the extension 180 degrees across from each other.Additionally, an impression of the guidewire coil was marked in the extension wall.This damage is consistent with clamping over the guidewire.The same leak test performed after the assembly process was again applied to the returned device, this time revealing the leak.As the device passed the leak test immediately after manufacturing and the impression of the guidewire coil is visible inside the tubing, it is determined the root cause is not manufacture related.The instructions for use (ifu) contains the following precaution: do not clamp over guidewire or stylet - tubing may become damaged.In addition, the catheter is packaged with a tag attached to a clamp that reads "do not clamp over guidewire or stylet".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: 11.5FX20CM HEMO-CATH ST
• Type of Device: HEMO-CATH ST
• 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: 17198025
• MDR Text Key: 318231598
• Report Number: 2518902-2023-00048
• Device Sequence Number: 1
• Product Code: MSD
• 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
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SL20E.
• Device Catalogue Number: SL20E.
• Device Lot Number: MPXL630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2021
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 77 KG